Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023
The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the Implementing Regulation (EU) 2023/1194 of 20 June 2023. To find out more about the extended deadlines, click here.
Addendum to MDCG Position Paper on the application of Article 97 | 30 June 2023
The position paper MDCG 2022-18 was published to provide a uniform approach to the application of Article 97 of MDR 2017/745 on medical devices (MDR) in situations where a certificate issued under the Directives has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR. The use of Article 97 MDR in those situations was meant to be a temporary solution. The goal of the position paper MDCG 2022-18 was to avoid a disruption of supply of devices on the EU market needed for health systems and patients.
Cybersecurity and privacy in AI – Medical imaging diagnosis | 07 June 2023
ENVISA has released a report on Cybersecurity and privacy in AI – Medical imaging diagnosis. This report allows better assessment of the reality that artificial intelligence brings its own set of threats, which consequently insists on the search for new security measures to counter them. This guide also strongly emphasises privacy issues in the same way as cybersecurity issues, privacy being one of the most important challenges facing society today. Security and privacy are intimately related, but both equally important, and a balance must be made specific to each use. As a result, as seen in this report, efforts to optimise security and privacy can often come at the expense of system performance.
FRANCE
ANSM notification on affixing barcodes for medical devices FSNs | 12 June 2023
n order to facilitate the identification of the devices affected by a field safety corrective action, ANSM recommends that manufacturers specify the following elements, directly in the field safety notice (FSN or appendix or web link that can be consulted directly):
Media allowing the automatic capture of data (one- or two-dimensional barcode) of the medical devices concerned, in particular those already having a UDI (unique device identification), for computerized inventory management.
The types of end recipients in the distribution chain concerned, to the manufacturer’s knowledge: pharmacy, pharmacy for indoor use, medical biology analysis laboratory, city care structure, large and medium-sized supermarkets, home healthcare provider …
The exhaustive list of references and batches or serial numbers targeted by the field safety corrective measure (unless all the batches are targeted).
FINLAND
Medical device distributors not required to submit device notifications until further notice | 06 June 2023
The Finnish Medicines Agency (Fimea) has temporarily waived the requirement for medical device distributors to submit device notifications in accordance with the Medical Devices Act. This decision aims to simplify the process and reduce the burden on distributors. Fimea has introduced an electronic submission service for operator details, but it currently does not include device data. The suspension of device notifications seeks to balance regulatory compliance and practicality.
IRELAND
HPRA notification on new case management system for medical devices | 06 June 2023
HPRA will implement a new case management system for medical devices from 6th June, resulting in changes to communication methods regarding cases.
Please read the information below carefully to ensure this transition does not impact your correspondence with us relating to your case.
Change of case reference number (CRN)
Previously, the HPRA market surveillance or vigilance case reference numbers were displayed as VXXXXX or MSXXXXX.
Case numbers will now be alphanumerical for example CRN00011X. HPRA will still be able to identify any closed or ongoing cases using the old reference numbers.
Changes to email communications
New cases will be assigned a dedicated e-mail address for example Case [email protected].
This will enable sending of case-specific communications directly to the allocated team.
E-mail correspondence sent to manufacturers from the HPRA that is relevant to the case will come from this dedicated e-mail address.
Please consult with IT departments within the organisation to ensure that e-mails of this nature are not blocked.
Please note that vigilance reports should continue to be submitted through [email protected]
ITALY
Clinical investigation on medical devices: four decrees published in Official Gazette | 16 June 2023
Two ministerial decrees were recently published in the Official Gazette on June 13, 2023, in relation to administrative procedures for clinical investigations of medical devices. The first decree focuses on applications for clinical investigation of devices that are either not CE marked or are CE marked but used outside their intended purpose. The second decree pertains to communications regarding clinical investigations on CE-marked devices used within their intended purpose. These decrees are in accordance with legislative decree n. 137/2022, which aligns national legislation with regulation (EU) 2017/745.
Effective from July 13, 2023, the decrees share a similar structure and aim to:
Identify the eligible entities to submit applications and communications for clinical investigations.
Clarify the procedures for submitting requests and communications related to clinical investigations.
Define the methods and timelines for obtaining the national-level opinion from an Ethics Committee.
Establish the means for communicating the initiation of investigations.
Additionally, two other ministerial decrees were published in the Official Gazette on June 14, 2023. The first decree focuses on ensuring the independence, transparency, and impartiality of the parties involved in handling clinical investigation requests. It aims to prevent conflicts of interest and undue influence, mandating specific declarations and requiring abstention in cases of conflicts of interest. The decree also allows for the involvement of experts with scientific and professional qualifications from research institutions, healthcare providers, or universities to evaluate survey questions.
The second decree addresses the requirements of suitable facilities for conducting clinical investigations aimed at demonstrating medical device conformity. It establishes that the assessment of facility suitability will be based on declarations submitted by the facilities’ legal representatives. Moreover, the decree permits remote testing of devices using digital technologies under specified conditions. Both decrees also implement provisions outlined in legislative decree n. 137/2022 (paragraphs 5 and 8 of article 16).
Initiation of SMEMDN project to update EMDN | 19 June 2023
TThe SMEMDN project, funded by the EU4Health 2022 Work Program, has officially begun. It aims to support and maintain the European Medical Device Nomenclature (EMDN) required by EU regulations for medical devices. The EMDN is based on the Italian classification system, the National Classification of Medical Devices (CND), which was adopted by the European Commission in 2019.
The project will last for 36 months and involves the Italian Ministry of Health and the Friuli Venezia Giulia Region. Its main objectives are to assist the European Commission in updating the EMDN, facilitate communication with member states and stakeholders regarding the nomenclature, provide tools to support the use of the EMDN, and collaborate with the World Health Organization.
The project follows a participatory approach, involving international stakeholders in maintaining and improving the EMDN. It considers technological advancements and evolving markets for medical devices. The EMDN has been used for medical device registrations in the European database for medical devices since October 2021.
UNITED KINGDOM (UK)
Updated Guidance on Borderline Products | 20 June 2023
Certain products can be challenging to categorize as they may share similarities with medicines, such as medical devices, cosmetics, food supplements, or biocidal products. These products are referred to as borderline products until their classification is determined.
The MHRA plays a crucial role in assessing the nature of these products. It determines whether a product meets the criteria for classification as a medicinal product and provides guidance on its status. Additionally, the MHRA evaluates whether a product should be classified as a medical device or falls under a different category. The guidance was updated on 20th June 2023.
Software and AI as a Medical Device Change Programme | 14 June 2023
Software (and AI in particular) plays an increasingly prominent role in health systems, having a wide set of applications across health and social care. Many of these applications will be regulated as medical devices. It is increasingly important then that medical device regulation be fit for purpose, to ensure patients, public, and healthcare professionals are empowered with the best medical technology available.
This work programme will deliver bold change to provide a regulatory framework that provides a high degree of protection for patients and public, but also make sure that the UK is the home of responsible innovation for medical device software.
MHRA / HRA Coordinated pathway | 20 June 2023
The MHRA and HRA have collaborated to establish a coordinated assessment pathway that simplifies the review process for clinical investigations with medical devices. This pathway enables parallel reviews by the MHRA and Research Ethics Committee (REC), ensuring efficient sharing of information and benefiting applicants
Regulating medical devices in UK | 20 June 2023
The UK medical device market is governed by the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance provides information on the UK system, including for:
Getting your device certified
Conformity marking your device.
Registering your device with the MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
Extended acceptance of CE marked medical devices on the Great Britain market | 01 July 2023
An extended timeframe for the acceptance of CE-marked medical devices on the British market is now implemented. This means that medical devices with the CE mark will be accepted on the British market after the current deadline of 30 June 2023.
As a result, CE marked medical devices may be placed on the Great Britain market to the following timelines:
General medical devices (MDs) compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner expiry of the certificate or 30 June 2030, and
General medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
SWITZERLAND
Medicinal products with a medical device component | 13 June 2023
Combination products are medicinal products with a medical device component. In the case of non-separable combinations (“integral” and “copackaged”), the combination product is not subject to the Medical Devices Ordinance. However, the medical device component must meet the basic safety and performance requirements according to Annex I EU-MDR.
For combination products (“integral” and “co-packaged”) currently authorised in Switzerland whose medical device component documentation also includes EU conformity certificates (CE certificates) for medical devices, the regulations on the validity of certificates set out in the changes to the EU-MDR will also apply.
If a new certificate is issued in accordance with EU-MDR, a separate application for variation does not have to be submitted. These certificates can be submitted together with another quality variation as an editorial change. If no other quality variations are planned in the near future, these certificates can also be submitted as a B.IV.1.z, type IA variation.
However, if the variation or new issuance of a certificate is the result of a significant change to the medical device component which affects/may affect the design or intended purpose or the quality, efficacy or safety of the combination product under medicinal product legislation, a separate application for variation must be submitted.
UNITED STATES OF AMERICA (USA)
Guidance on Premarket submission for Device Software Functions | 10 April 2023
FDA has released a new guidance document on the Content of Premarket Submissions for Device Software Functions. This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
AUSTRALIA
New guidance published on manufacturer evidence for IVD medical devices | 20 June 2023
TGA no longer accepts ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a Declaration of Conformity under the EU IVD Directive before 26 May 2022.
IVD medical devices that are already approved for supply based on ISO 13485 certificates will need to transition to another form of acceptable manufacturer evidence once the certificate expires, to continue to supply in Australia.
This guidance helps sponsors identify the actions they must take to transition to new manufacturer evidence and ensure ongoing regulatory compliance.
SINGAPORE
HSA’s SRA status for in vitro diagnostic medical devices (IVD)| 16 June 2023
The Health Sciences Authority (HSA) has been recognized by the WHO as the Strict Regulatory Authority (SRA) for high-risk In Vitro Diagnostic Devices (IVD). This recognition allows HSA-registered IVDs to undergo an abbreviated WHO prequalification assessment, facilitating rapid access to international markets. HSA’s SRA status reflects its commitment to maintaining quality standards and improving public health.
MALAYSIA
Transition period for the use of electronic medical device certificates | 22 May 2023
The Medical Device Authority (MDA) will implement the use of electronic medical device registration certificates starting May 2, 2023 . The establishment can download the medical device registration certificate from the [email protected]+ system once the application is complete (status complete ) and the registration fee has been paid. The use of electronic medical device registration certificates will be fully implemented from 1 January 2024 and no more physical medical device registration certificates will be issued by MDA.
BRAZIL
Anvisa publishes new medical device import manual | 22 June 2023
The new Manual for Importing Medical Devices is available on Anvisa’s portal . The document aims to guide importers on the rules for submission and procedures for analyzing import processes .
The subjects are organized into topics , which help consultation on the regularization of companies and products, procedural instruction and analysis and inspection procedures . The specific legislation and situations applicable to each topic are also indicated.
This publication is not intended to replace the guidelines on petitioning for the import process already published by the Agency or the manual available on the Siscomex Portal . The idea is to complement this information on specific aspects of consent to import medical devices in the context of Anvisa.
Users will be able to evaluate requests for medical devices | 20 June 2023
Those who use the medical device application service will be able to evaluate the process with Anvisa. The implementation of the evaluation will start from this Wednesday ( 21/6). The functionality is being gradually expanded to all requests made through the Solicita system , with the sanitizing area being the pioneer in implementing the service.
At the end of each request process, a link is provided for the user to send their opinion about the service request in the Request. The purpose of the assessment is to improve the provision of services offered by the Agency .
Another improvement that will be implemented is the categorization of services, to facilitate the location of the desired subjects, in addition to the other filters already available. The system will display only the subjects available for the selected process, reducing the possibility of errors in the petitions.
In addition, it will be possible to consult which service is associated with each subject and which other services are related (list of parent and child services) in the consultation tool available at https://consultas.anvisa.gov.br/#/consultadeassuntos/.
If the user identifies any lack of subject or service, he is requested to contact the appropriate area and describe the problem.
COSMETICS
EUROPEAN UNION
EU Proposes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics | 27 June 2023
On June 22, 2023, the EU introduced new amendments to Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through a draft regulation notified to WTO. This draft proposes to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics as well as other consumer and professional products. It is currently open for comment until August 21, 2023.
EU to Implement a Union-wide Ban on PFHxA in Cosmetics | 21 June 2023
On June 19, 2023, the EU notified WTO of a draft regulation aiming at amending the Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This draft proposes to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics. It is currently open for comment until August 18, 2023.
EU to Adopt Changes to Use Requirements for cosmetic ingredients | 14 June 2023
The EU introduced 11 changes to the ingredient lists in Cosmetics Regulation, including:
1) Adding one prohibited ingredient, and eight restricted ingredients;
2) Amending the use requirements for two permitted preservatives.
On June 8, 2023, EU notified WTO of a draft regulation that aims at revising the ingredient lists in Regulation (EC) No 1223/2009 (Cosmetics Regulation). The draft proposes to prohibit and restrict the use of certain cosmetic ingredients respectively, following the opinions from the Scientific Committee on Consumer Safety (SCCS), and is open for comments until August 7, 2023.
CANADA
Canada Bans Cosmetic Animal Testing | 27 June 2023
On 27th June 2023 , the Honourable Jean-Yves Duclos, Minister of Health, announced that the Government of Canada has banned the cruel and unnecessary testing of cosmetic products on animals in Canada, representing a major step forward in supporting animal welfare by reducing our reliance on animal testing, while ensuring health and safety.
With the passing of Bill C-47, Budget Implementation Act, 2023, No. 1, the Food and Drugs Act (FDA) has been amended to ban cosmetic animal testing. The new legislative changes mean that in Canada, companies will no longer be allowed to test cosmetic products on animals or sell their cosmetics that rely on animal testing data to establish safety.
The practice of testing cosmetics on animals has significantly decreased worldwide and was rarely conducted in Canada. By implementing these changes, Canada is aligning with the global shift toward ethical cosmetic testing by joining other countries, including all European Union countries, Australia, the United Kingdom, and South Korea, that have already taken measures to prohibit cosmetic animal testing.
Beyond cosmetics, Health Canada is working with the international scientific and regulatory community to develop, validate and implement effective alternatives to animal testing. This includes providing continued leadership and contributions to the work of various committees and organizations, such as the Organisation for Economic Co-operation and Development (OECD) and the International Cooperation on Alternative Test Methods (ICATM).
CHINA
China NIFDC Consults on Updates to Prohibited Ingredients and Toxicological Test Methods for Cosmetics | 14 June 2023
On June 12, 2023, China’s National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on proposed updates to the Inventory of Prohibited Ingredients for Cosmetics, along with the introduction of test methods for cosmetic ingredients. Interested parties are invited to provide their feedback and suggestions until July 15, 2023, by submitting the Feedback Form via email to [email protected].
Additionally, the consultation highlights the introduction of seven draft test methods for the toxicological test of cosmetic ingredients, which are developed according to Organization for Economic Co-operation and Development (OECD) guidelines. Notably, the draft U937 Cell Line Activation Test is a new animal testing alternative specifically for skin sensitization. It complements the existing skin sensitization test method in the Safety and Technical Standards for Cosmetics 2015 and aligns with the global movement towards cruelty-free practices.
China NIFDC Clarifies Detailed Registration Requirements for Special Cosmetics and New Cosmetic Ingredients | 26 June 2023
On June 5, 2023, China National Institutes for Food and Drug Control (NIFDC) released nine guidelines pertaining to the registration of Chinese domestic and imported special cosmetics, as well as high-risk new cosmetic ingredients (NCIs). 1 These guidelines provide clear details and time limits for the first registration, registration change, registration renewal and registration cancellation applications, which are highly informative for enterprises seeking guidance.
The latest guidelines are titled as follows:
Guidelines for the Approval of Registration of New Cosmetic Ingredients with High Risks
Guidelines for the Approval of Registration Change of Chinese Domestic Special Cosmetics
Guidelines for the Approval of Initial Registration of Chinese Domestic Special Cosmetics
Guidelines for the Approval of Registration Renewal of Chinese Domestic Special Cosmetics
Guidelines for the Approval of Registration Cancellation of Chinese Domestic Special Cosmetics (Cancellation upon Application)
Guidelines for the Approval of Registration Change of Imported Special Cosmetics
Guidelines for the Approval of Initial Registration of Imported Special Cosmetics
Guidelines for the Approval of Registration Renewal of Imported Special Cosmetics
Guidelines for the Approval of Registration Cancellation of Imported Special Cosmetics (Cancellation upon Application)
The main content of these guidelines include:
Administrative licensing item name and code
Sub-item name and code of administrative licensing
Business items that need to be handled
Competent authority
The Guidelines’ establishment and implementation basis
Executive agency
Approval levels
Types of administrative licensing items
Licensing conditions
Application documents
Intermediary services
Approval procedures
Acceptance and approval time limit
Fees
Administrative license
INDIA
India Proposes Amendments to Cosmetics Rules 2020 | 05 June 2023
The proposed changes cover terminology modifications, the introduction of new rules, the relaxation of certain regulatory requirements, and various other adjustments.
On May 17, 2023, the Ministry of Health and Family Welfare of India initiated a public consultation on proposed amendments to the Cosmetics Rules 2020, with the goal of improving the regulation and quality control of cosmetics in India. The consultation period lasts 45 days, during which stakeholders are encouraged to provide feedback and suggestions to the Ministry, either by mail (see Notes at the end of the article for detailed address) or by email to [email protected].
THAILAND
Thailand Cosmetics Regulation Update: Release of Prohibited ingredient list | 30 June 2023
Thailand has recently implemented changes in the cosmetics regulations, introducing a new list of prohibited ingredients and updating the requirements for permitted preservatives. The latest updates now align Thailand’s regulations with the latest ASEAN Cosmetic Directive revisions.
On June 22, 2023, the Ministry of Public Health of Thailand (MOPH) issued three notices through the 140th Government Gazette of 2023, detailing the regulatory revisions pertaining to prohibited ingredients and permitted preservatives in cosmetics. These notices officially came into effect on June 23, with a transition period applying to some rules.
ISO STANDARDS
List of Updated ISO standards for June 2023
BS EN ISO 19979:2023 Ophthalmic optics. Contact lenses. Hygienic management of multi-patient use trial contact lenses (ISO 19979:2018)
BS EN IEC 61676:2023 Medical electrical equipment. Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology.
Updated guidance on significant changes under MDR | 12 May 2023
The guidance document MDCG 2020-3 Rev.1 is intended to clarify the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices.
This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design or substantial changes to the approved quality system or the product range covered.
Commission guidance on content and structure of summary of clinical investigation report | 08 May 2023
The document is intended to provide Commission guidance, following Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary of the clinical investigation report.
The guidance aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis and results of the clinical investigation in terms and in a format that is easily understandable to the intended user of the medical device.
UNITED KINGDOM (UK)
New regulatory pathway for innovative medical technologies | 26 May 2023
Plans are advancing for a new regulatory pathway that facilitates the development of innovative technologies by providing innovators and manufacturers with a multi-partner support service, including targeted scientific advice that brings new products to patients sooner. The Innovative Devices Access Pathway (IDAP), set for launch later in 2023, will be operated by the Medicines and Healthcare Products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and Scottish Health Technology Group (SHTG). Innovators of medical technology (commercial or non-commercial, UK based or international) that address clinical needs are encouraged to register for further information before a planned 2023 pilot launch. Please send an email with details to [email protected].
Regulatory status of equipment to prevent COVID-19 | 17 May 2023
Different regulations apply to devices and equipment including hand gels, face masks and coverings and PPE (personal protective equipment). The latest MHRA guidance helps manufacturers of equipment that are used to prevent COVID-19 to choose the right regulatory pathway to market the product in the Great Britain market.
MHRA guidance on Medical Device regulation and enforcement | 17 May 2023
MHRA is responsible for checking that medical devices in the UK comply with legal requirements.
Contact details to report a non-compliant medical device
Information on MHRA’s enforcement duties after receiving a complaint
MHRA’s routine monitoring role
the manufacturer’s rights if they have received an enforcement notice
The government intends to extend acceptance of CE-marked devices in Great Britain beyond 30 June 2023. For more detail on this, visit the implementation update page. The guidance also contains crucial information on reporting non-compliant medical devices to MHRA.
MHRA guidance on Off-label use of medical devices | 17 May 2023
The latest MHRA guidance on off-label use was released on 17th May 2023. Medical devices should be used as described by the manufacturer in the instructions. If the device is used in any other way, it’s considered ‘off-label’ use.
Off-label use of a device could lead to dangers including:
Misuse due to lack of adequate training for the device
The guidance contains some common examples of problems with off-label use.
MHRA guidance on Class I medical devices | 17 May 2023
This updated guidance applies to manufacturers of Class I medical devices, including accessories but excludes devices intended for clinical investigation and custom-made devices. The guidance covers crucial topics such as UKCA marking, technical documentation for Class I medical devices, clinical evaluation and post-market requirements.
MHRA guidance on legal requirements for prosthetic, orthotic and ophthalmic devices | 17 May 2023
MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices. The guidance includes information on the following aspects:
Classification
Custom-made prosthetic, orthotic and ophthalmic devices
Examples
Registration of devices in the UK
MHRA guidance on DEHP phthalates in medical devices | 17 May 2023
The latest MHRA guidance on DEHP phthalates in medical devices, released on 17th May, describes the safe use of phthalates in medical devices. Phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible. Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices such as:
Intravenous (IV) tubing
Umbilical artery catheters
Blood bags and infusion tubing
Enteral nutrition feeding bags
Nasogastric tubes
MHRA guidance on software applications medical devices | 17 May 2023
This updated guidance applies to software applications considered to be medical devices and how they are regulated. The guidance is now updated with Medical device stand-alone software, including apps’ with the implementation of new regulations, updates to various links, including MORE and new software vigilance guidance. The guidance can be accessed here.
MHRA guidance on virtual manufacturing of medical device | 17 May 2023
MHRA has released an updated version of the guidance for manufacturers who don’t design or manufacture devices but place their names on the product. A “virtual manufacturer” is an organisation that fully sources its own named product from another company (sometimes known as the ‘original equipment manufacturer’), which has designed and manufactured an identical UKCA/CE/CE UKNI marked product. In practice there is no difference in the regulatory requirements applying to a manufacturer and a virtual manufacturer.
Extension of acceptance of CE marked devices in Great Britain | 01 May 2023
CE-marked medical devices are expected to be accepted in Great Britain for an extended period. A statutory instrument has been laid in Parliament, enabling an extended timeframe for acceptance of CE-marked medical devices on the Great Britain market.
Subject to Parliamentary approval, this will mean that CE-marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023.
SWITZERLAND
Swiss guidelines on reprocessing in healthcare institutions | 20 May 2023
Update of the Swiss guideline based on SN EN ISO 17665, taking account of, and applying, the contents of SN EN 285. The requirements regarding reprocessing are set out in Article 72 of the Medical Devices Ordinance (MedDO). Medical devices intended for multiple use or single use that are not supplied in sterile condition must be reprocessed before use in accordance with the current state of technology and science, taking account of the manufacturer’s instructions and the requirements of good hygiene. The updated guidance can be accessed here.
AUSTRALIA
Phase out of ISO 13485 certificates for IVD medical devices | 25 May 2023
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26 May 2023.
This means TGA can no longer accept ISO 13485 certificates to support IVD inclusion applications. Approved IVD medical devices supported by ISO 13485 certificates remain valid until the certificate expires. Sponsors will then need another form of acceptable manufacturer evidence to support their approved device. The other supported evidence for TGA inclusion can be accessed here.
EU MDR transition extension | 05 May 2023
The TGA recently implemented an EU MDR transition strategy for Australian medical device sponsors and stakeholders. More recently, the EU extended the transition, prompting the TGA to review its strategy and to review the impact on reclassification reforms underway in Australia.
UNITED STATES OF AMERICA (USA)
FDA guidance on Laparoscopic power morcellators | 25 May 2023
Laparoscopic power morcellators are Class II medical devices used during laparoscopic surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site (typically 2 cm long or less). The guidance document provides the FDA’s recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems and may also help manufacturers comply with the special controls related to non-clinical performance data for these devices. This guidance recommends non-clinical test methods that may help manufacturers meet the non-clinical performance data requirements identified in the special controls codified in 21 CFR 884.4050(b)(4) (for gynaecologic use) and 21 CFR 878.4825(b)(4) (for general use), and also includes other non-clinical testing recommendations to support a 510(k) submission/substantial equivalence determination.
MDSAP QMS Documents | 23 May 2023
The Medical Device Single Audit Program allows an MDSAP-recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. FDA has published MDSAP QMS documents and MDSAP QMS Procedures and Forms for the general public.
CANADA
Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies | 23 May 2023
On the 22nd of February, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) came into force. These regulatory amendments resulted in the creation of Part 1.1 of the MDR. Part 1.1 is a permanent regulatory framework for COVID-19 medical devices.
Health Canada is proposing to expand the scope of Part 1.1 to:
Apply to other medical conditions that result in significant risk to public health in Canada, and immediate action is required to deal with the risk
Include medical devices for which there is a UPHN to diagnose, treat, mitigate or prevent these medical conditions
Database for In vitro diagnostics medical devices notification | 25 April 2023
In Vitro Diagnostic Medical Devices Notifications includes notifications on the first placing of in vitro diagnostics on the market (according to § 25 MPG – Act on Medical Devices). The database is part of the German database-supported medical devices information and database system. Included therein is mainly administrative data and further data relevant to the notification.
Finland
Electronic submissions for medical devices will be opened on 2nd May | 06 April 2023
Fimea’s new electronic submission service will be opened for medical device operators on 2 May 2023. The electronic submission service is used for reporting data to the national CERE register by
Self-manufacturers of social welfare and health care units,
Manufacturer of custom-made devices, excluding manufacturers of risk class III implantable devices (notified body used in the assessment), and
Distributors liable to file a notification.
UNITED KINGDOM (UK)
Software and Artificial Intelligence as a medical device | 06 April 2023
AI and software play a crucial role in health and social care. Numerous of these items are governed as medical devices or in vitro diagnostic medical devices (IVDs) in the UK. Access to significant Software Group outputs that may be useful is provided in this guidance. Click here to download the guidance on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD)
Guidance for manufacturers on vigilance | 24 April 2023
The medical device vigilance system involves reporting and evaluating adverse incidents and safety corrective actions related to medical devices. This system is described in detail in the MEDDEV 2.12/1 rev 8 guidelines and additional guidance on post-market surveillance, which provide information on what incidents to report, how to report them, and when to do so for medical devices on the UK market
Register medical devices to place on the market | 27 April 2023
Before being sold in Great Britain (England, Wales, and Scotland), all medical devices, including IVDs, custom made devices, or procedure packs, must be registered with the MHRA. To be sold and registered with the MHRA, devices in Great Britain must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), which are in effect there. Only manufacturers or UK Responsible Persons with a physical presence in the UK, or Northern Ireland-based Authorized Representatives (for the purposes of the Northern Ireland market), may register devices with the MHRA.
Implementation of medical device future regime | 27 April 2023
The MHRA released the government’s response to the public consultation on the future oversight of medical devices in the UK on June 26, 2022. The response described the planned regulatory reform, as well as the transitional plans for CE and UKCA marked devices sold in the United Kingdom. an update on the timelines to implement the future Medical Device Regulations can be found here (Implementation of medical devices future regime)
Regulating medical devices in UK | 28 April 2023
The UK medical device market is governed by the Medicines and Healthcare Products Regulatory Agency (MHRA). This guidance provides information on the UK system, including for:
Getting your device certified
Conformity marking your device.
Registering your device with the MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
Extended acceptance of CE marked medical devices on the Great Britain market | 28 April 2023
An extended timeframe for the acceptance of CE-marked medical devices on the British market has been made possible by a statutory instrument that has been laid before Parliament. This means that subject to parliamentary approval, medical devices with the CE mark will be accepted on the British market after the current deadline of 30 June 2023.
SWITZERLAND
Announcements on clinical trial with medical devices and performance studies with In vitro medical devices | 13 April 2023
The instructions for submitting combined trials and for submitting previously authorized trials that are now being converted to combined trials have been updated by SwissMedic.
UNITED STATES OF AMERICA (USA)
Agency Information Collection Activities | 10 April 2023
The Food and Drug Administration (FDA) is making the public aware of an opportunity to comment on the Agency’s proposed collection of specific information. Federal agencies are required to publish notice in the Federal Register under the Paperwork Reduction Act of 1995 (PRA). regarding each proposed data collection, including any proposed extensions to already-existing data collections, and to give the public 60 days to respond to the notice with comments. In this notice, the Centre for Devices and Radiological Health of the FDA is seeking feedback on the information gathering related to reports of removals and corrections for medical and radiation emitting products.
Sterilization for medical devices | 11 April 2023
The Radiation Sterilization Master File Pilot Program has been announced by the FDA. This voluntary pilot program aims to assist businesses in developing less onerous regulatory methods for sterilizing approved medical devices, including new radiation sources. Under the specific conditions outlined in the notice, the pilot will be accessible to nine companies that sterilize single-use, PMA-approved medical devices using gamma radiation or ethylene oxide (EtO) and intend to submit master files when making certain changes to sterilization sites, sterilization methods, or other processes.
Guidance for Industry and Food and Drug Administration Staff | 13 April 2023
At-Home OTC COVID-19 Diagnostic Tests | 17 April 2023
The FDA has provided information on at-home over-the-counter (OTC) COVID-19 diagnostic tests, which are authorized for self-testing. These tests allow individuals to collect their own sample, perform the test, and read the result without needing to send a sample to a laboratory. There are two types of diagnostic tests available: molecular and antigen, with most authorized at-home OTC COVID-19 tests being antigen tests. However, users of antigen tests should repeat testing following a negative result, whether they have symptoms or not, to reduce the risk of a false negative test result. For more information, the FDA has issued a safety communication on the matter.
In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola | 19 April 2023
The Food and Drug Administration (FDA) has announced the revocation of Emergency Use Authorizations (EUAs) previously issued to BioFire Defense, LLC, and Biocartis NV. The FDA revoked the EUAs for the FilmArray NGDS BT-E Assay and the Idylla Rapid Ebola Virus Triage Test under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by each Authorization holder.
In Vitro Diagnostics EUAs – Molecular Diagnostic Tests for SARS-CoV-2 | 19 April 2023
The FDA has released two final guidance to transition from COVID-19 policies to normal operations for medical devices. The guidances provide recommendations for developing a transition implementation plan, submitting a marketing submission, and taking other necessary actions. Manufacturers seeking marketing authorization should start working on a submission and transition plan. The FDA encourages stakeholders to review the guidance, attend the webinar, and reach out with any questions or concerns.
Orthopaedic and rehabilitation devices panel of the medical devices advisory committee meeting announcement | 20 April 2023
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The committee’s primary responsibility is to advise and counsel the Agency on FDA regulatory matters. The public is welcome to attend the meeting.
TIME: From 9 a.m. to 6 p.m. Eastern Time on April 20, 2023, a virtual meeting will be held.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
Guidance on MDR transitional period extension| 28 March 2023
The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, deleting the ‘sell off’ date in the MDR and the IVDR aims to prevent the unnecessary disposal of safe devices.
For more information on Regulation (EU) 2023/607 regarding the extension of transitional periods, click here.
MDCG ongoing guidance development | 10 March 2023
MDCG has released a list of guidance documents to be published in 2023. The list contains the ongoing guidance development and deliverables of MDCG Subgroups. The complete list can be accessed here.
ITALY
Ethics committees for clinical investigations with medical devices | 06 March 2023
Italian authorities have announced recent changes to regulations governing clinical trials on medical devices and medicines. The changes include four ministerial decrees issued in February 2023 and a Ministry circular providing implementation guidance. The circular details criteria for the composition and functioning of territorial ethics committees and identifies 40 such committees. Previous guidance provided in the Circular of 25 May 2021 will need to be updated to reflect the changes. The authorities have also called for clarification on similarities and differences between clinical investigations on medical devices and clinical trials on medicines, particularly in regard to tariff systems and the transitional phase between the publication of the decrees and the full operation of the 40 territorial ethics committees. These changes aim to ensure patient safety and proper regulation of clinical trials.
RUSSIA
Roszdravnadzor’s licenses for maintenance of medical devices | 20 March 2023
Roszdravnadzor has significantly simplified the licencing procedure by removing all paperwork involved in licence application and issuance. Instead of paper documents, a legally important entry is created in Roszdravnadzor’s information resource as a result of the provision of state licencing services.
The terms for providing licencing services have been cut three times (from 45 to 15 working days), and the terms for making changes to the register of licences have also been cut, going from 30 to 13 working days, in an effort to lessen the administrative burden on legal entities and individual entrepreneurs. It should be noted that more than 500 service organisations have issued new licences
UNITED KINGDOM (UK)
Export Certificates for medical devices | 27 March 2023
To export medical devices, a Certificate of Free Sale (CFS) may be required. A CFS can only be ordered for medical devices and IVDs that have been registered with the MHRA on our Device Online Registration System (DORS). In vitro diagnostic medical devices for performance evaluation cannot be included in CFS orders.
A CFS can only be ordered by a UK-based manufacturer, UK Responsible Person or Northern Ireland-based Authorised Representative. You will have to provide evidence that the medical devices you are exporting have relevant conformity assessment marks (UKCA, CE, CE UKNI) to show compliance with the UK Medical Devices Regulations 2002 (as amended) that enable them to be placed on the UK market. Reference guide on Certificates of Free sale can be found here.
Intended Purpose Guidance on SaMD| 22 March 2023
Crafting an intended purpose for software as a medical device (SaMD) involves identifying the target user, defining the medical purpose and intended benefit, addressing potential risks, using specific and evidence-based language, and seeking stakeholder input. It is important to ensure that the purpose is clear, concise, and accurately reflects the intended use of the software in the context of medical treatment or diagnosis. This guidance document provides guidance on defining intended purpose for Software as a Medical Device (SaMD). It is intended to assist SaMD manufacturers in meeting their statutory obligations.
Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. | 17 March 2023
The advisory group discussed proposals for reforming the UK’s regulatory system for HealthTech products, with the aim of making the UK the first-place innovators in bringing novel HealthTech for approvals and providing world-class support for innovators and patient safety. The group focused on three areas: international recognition, routes for innovation, and system capacity, and identified the need for a proportionate regulatory system that recognizes the decisions of trusted regulators, early engagement with innovators, and sufficient regulatory expertise. The proposals require further policy development and impact assessment, and the MHRA will develop a roadmap. The group committed to establishing a phase two advisory group to maintain momentum and complete the work needed by the end of April.
MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical product| 15 March 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) will receive £10 million from HM Treasury to speed up the approval process for innovative medical products, enabling faster access for UK patients. This funding will be used to establish a quicker approval process for cutting-edge treatments, including cancer vaccines and AI-based therapeutics for mental health. The MHRA will also establish an international recognition framework with regulatory partners such as the FDA and PMDA to facilitate fast-track access to approved medical products.
UNITED STATES OF AMERICA (USA)
Cybersecurity Guidance| 27 March 2023
All legally-marketed medical devices have benefits and risks. The FDA clears, authorizes, and approves devices to be marketed when there is a reasonable assurance that the devices are safe and effective for their intended use.
Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. These same features also increase potential cybersecurity risks. The latest guidance on cybersecurity provides information on mitigating cybersecurity risks, reporting cybersecurity risks and other crucial topics.
Updated Guidance on eSTAR submissions| 23 March 2023
The eSTAR is a PDF form for the process of preparing a medical device submission. This template contains:
Automation (for example, form construction and autofill)
Content and structure that is complementary to CDRH internal review templates
Integration of multiple resources (for example, guidances and databases)
Guided construction for each submission section
Automatic verification
The latest requirements for eSTAR application can be accessed here.
CANADA
Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies | 23 March 2023
On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) came into force. These regulatory amendments resulted in the creation of Part 1.1 of the MDR. Part 1.1 is a permanent regulatory framework for COVID-19 medical devices.
Health Canada is proposing to expand the scope of Part 1.1 to:
Apply to other medical conditions that result in significant risk to public health in Canada, and immediate action is required to deal with the risk
Include medical devices for which there is a UPHN to diagnose, treat, mitigate or prevent these medical conditions
BRAZIL
Anvisa notification to check medical device documentation | 14 March 2023
The latest Resolution of the Collegiate Board (RDC) 751/2022 replaces the older Resolution of the Collegiate Board (RDC) 185/2001. The new standard provides for risk classification, reporting and registration regimes, labelling requirements, and instructions for the use of medical devices.
RDC 751/2022 promotes the internalization of Mercosur GMC Resolution No. 25/2021, which, at the initiative of Brazil, updated the document requirements and classification rules for medical devices applicable to the region. In addition to the internalization of the norm, the text consolidates a series of other regulations issued by Anvisa that deal with the regularization of medical devices.
BRAZIL
MDA Guidance on notification of custom-made medical devices products | 01 March 2023
The Medical Device Authority of Malaysia has released a guidance to help the industry and healthcare professionals comply with the Medical Device Act (Act 737) and its regulations. The guidance provides information on the requirements of custom-made medical devices that are eligible to be exempted under the Medical Device (Exemption )Order 2016. The requirements include:
Devices must meet the criteria of the custom-made medical device, including obtaining the written prescription and specific design characteristics from a healthcare professional
Classification of the device according to the device classification as specified in the First Schedule of Medical Device Regulation 2012
The device is safe and performs as intended
CHINA
Guidelines for registration of laparoscopic endoscopic surgery systems| 23 March 2023
The purpose of these guidelines is to guide the registration applicant in the preparation and writing of the registration application materials for laparoscopic endoscopic surgical systems (hereinafter referred to as surgical systems) with surgical instruments that do not provide energy to patients and high-frequency surgical instruments (hereinafter referred to as surgical instruments), and also to provide reference for the technical review department to review the registration application materials.
Draft Amendments in the Drugs Rules 1976 and the Medical Device Rules, 2017 | 03 March 2023
NMPA has issued guidelines for reviewing and registering Dental Adhesive Products and Artificial shoulder prostheses. The purpose of these guidelines is to guide the registration applicant in preparing and writing the registration application materials.
Anvisa regularization of hair ointment | 22 March 2023
Anvisa decided the suspension of new notifications for the regularisation of products like pomades for braiding, styling, or fixing hair as a measure of health concern in Order 31, of March 22, 2023. The measure is in effect for the duration of the precautionary ban set forth in Resolution – RE 914 of March 17, 2023.
Anvisa’s resolution RE 914/2023 kept the precautionary ban on goods not on the list of authorised products while allowing the return of a limited number of hair ointments to the market. Due to reports of severe adverse events connected to eye poisoning, the ban was authorised.
The order, which was published this Wednesday (4/22) maintained the requirement that businesses attach a 30-day Term of Responsibility to their respective processes in order to regularise ointments for braiding, styling, or fixing hair that are on the list of authorised products. After carefully examining the product for which they are responsible, businesses are required to state that no significant adverse events have been associated with the product since its introduction to the market. They must also guarantee their safety and excellence.
The product may be taken off the list of authorised goods if the Term of Responsibility is not presented within the time frame set by the Agency. The Collegiate Board of Anvisa decided beforehand, in light of the impending health risk, to remove the suspensive impact of any administrative appeals that are submitted in response to Resolution – RE 914/2023. This decision was made through Dispatch 31/2023. The measure also pertains to registration cancellation resolutions relating to creams for hair braiding, styling, or fixing that were modified as of 12/1/2022.
Brazil Bans Animal Testing for Cosmetics | 20 March 2023
Brazil’s National Council for the Control of Animal Experimentation (CONCEA) passed Resolution No. 58 on February 24, 2023, and it became effective on March 1.
The Resolution forbids using vertebrates (apart from humans) in scientific study and creating and testing cosmetics, perfumes, and personal care items. This prohibition covers the aforementioned goods made with substances or ingredients that have already been shown to be secure and efficient.
The Resolution states that it is mandatory to use the alternate methods accepted by CONCEA for products added with ingredients or compounds whose safety and efficacy have yet to be established. Additionally, it is permitted to use alternative techniques that have received national or foreign validation but have yet to be approved by CONCEA.
On Feb. 11, 2023, Health Canada (HC) published the Canada Gazette, Part I, Volume 157, Number 6. According to the Gazette, the Government of Canada plans to amend Cosmetic Regulations, requiring cosmetics to be labelled with fragrance allergens, allowing the disclosure of the full ingredient list of cosmetics sold in small packages on the website, and modifying cosmetic supervision requirements.
On March 27, 2023, China’s National Medical Products Administration (NMPA) announced adjustments to its management policies on the submission of cosmetic ingredient safety information, relaxing certain regulatory requirements. This move is in response to some enterprises experiencing difficulties in obtaining the necessary documents due to factors such as the COVID-19 pandemic.
The key highlights of the NMPA announcement are as follows:
The ingredient safety information documents for ingredients without an ingredient submission number can now be completed and submitted by themselves by cosmetics registrants and notifiers
The policies for submitting safety information about cosmetic ingredient ingredients will now go into effect on January 1, 2024, after a transition time
Only specified categories of ingredients are needed to supplement their safety information for all cosmetics registered and notified before 2024
According to Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be managed with reference to the provisions on general cosmetics. In order to implement this provision and standardize the supervision of toothpaste, on March 23, 2023, China State Administration for Market Regulation (SAMR) issued the finalized Administrative Measures on Toothpaste (Measures). It will be implemented on December 1, 2023.
On March 23, 2023, China SAMR issued the finalized Administrative Measures on Toothpaste, which clarified the following:
The responsibilities of all stakeholders
Toothpaste’s definition
Management requirements for toothpaste products and new ingredients
Requirements for toothpaste safety assessment, efficacy claims and labelling
Ongoing use of the existing toothpaste production licensing system
China Consults on the First Regulation for Freckle-Removing and Whitening Cosmetic Ingredients| 24 March 2023
The two guidelines are devised to regulate further and guide the research and evaluation of cosmetics and ingredients with freckle-removing and whitening efficacies so as to improve the safety and quality of cosmetics and promote industry research and innovation. For R&D, safety assessment, efficacy evaluation, manufacturing, quality control, and labelling of freckle-removal and whitening cosmetics, the former draught regulation offers technical advice. The latter offers technical advice and scientific recommendations to help cosmetic applicants investigate and assess whitening ingredients.
In September 2020 and June 2022, China NMPA issued two drafts of Measures for the Management of Cosmetic Sampling Testing (Measures). Finally, on January 12, 2023, NMPA released the finalized Measures, which will be implemented on March 1, 2023.
The Measures is divided into 8 chapters and 61 articles, providing detailed requirements on the formulation of sampling testing work plan, sampling, testing and result submission, objection and re-testing, verification and disposal of unqualified products, and information disclosure. The key points are summarized and analyzed as follows.
UNITED KINGDOM
Ingredients upload for submitting product notification | 27 March 2023
New functionality will shortly be available when submitting new product notifications. You will now have the option to upload ingredients through a CSV file. Instructions on how to develop the CSV file can be found here:
This new feature will be available initially when entering ingredients by exact concentration. The functionality to upload ingredients with shades and concentration ranges will be available later in 2023.
The applier can still add ingredients manually and by selecting a frame formulation. This feature forms part of our continued work programme to improve the service.
UNITED STATES OF AMERICA
Tighter Rules Now in Effect for USDA Organic Seal of Approval | 28 March 2023
As of March 20, 2023, the U.S. Department of Agriculture’s (USDA’s) Strengthening Organic Enforcement (SOE) final rule goes into effect, tightening the oversight and enforcement of the production, handling and sale of organic products. The goal is to protect integrity in the organic supply chain and build consumer and industry trust in the USDA organic label by strengthening organic control systems, improving farm-to-market traceability, and robustly enforcing USDA organic regulations.
Key updates include:
Requiring certification of more of the businesses, like brokers and traders, at critical links in organic supply chains
Requiring National Organic Program (NOP) Import Certificates for all organic imports
Requiring organic identification on nonretail containers
Increasing authority for more rigorous on-site inspections of certified operations
Requiring uniform qualification and training standards for organic inspectors and certifying agent personnel
Requiring standardized certificates of organic operation
Requiring additional and more frequent reporting of data on certified operations
Creating authority for more robust recordkeeping, traceability practices and fraud prevention procedures and
Specifying certification requirements for producer groups
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
MDCG guidance on vigilance terms and concepts of EU MDR| 14 February 2023
The MDCG 2023-3 guidance document clarifies some of the essential terms and concepts in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). The topics covered in the guidance document are as follows:
Difference between Incident and Serious incident
Reportability under EU MDR
Definition of malfunction or deterioration in the characteristics or performance of a device with examples
Use error vs abnormal use
Timelines to report an incident
MDCG Guidance on Classification of IVD under IVDR | 10 February 2023
The MDCG 2020-16 rev.2 guidance addresses the requirement for the classification of IVDs under the classification rules set out in Annex VIII. This document’s primary purpose is to guide manufacturers, notified bodies and health institutions on how to classify an IVD before placing it on the market, making it available on the market or putting it into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution. More information about IVD classification rules can be found here.
CZECH REPUBLIC
Guidance on implementation of Article 97 in Czech Republic | 02 February 2023
If you supply the Czech market with a medical device to which the procedure according to Article 97 of the MDR has been applied by the competent authority of another Member State due to the expiry of the validity of the EC certificate issued according to Directive 93/42/EEC or 90/385/EEC and the not yet existing EC certificate according to the MDR , it is necessary to request a decision of the competent authority on this procedure from the manufacturer of the medical device in question. This decision temporarily replaces the missing EC certificate and declaration of conformity, by which the manufacturer proves the conformity of the medical device with the relevant legislative requirements
BfArM Guidance on Companion diagnostics (CDx) | 08 February 2023
A companion diagnostic (CDx) is defined in article 2(7) of IVDR 2017/746 as follows:
“companion diagnostic” means a device which is essential for the safe and effective use of a corresponding medicinal product to:
Identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
Identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product
Whether an IVD fulfils the criteria of a CDx depends on whether detecting the biomarker status is necessary for the therapy decision to ensure the safe and effective use of the medicinal product. The analytical quality of detecting a certain biomarker is not a sufficient criterion for a CDx.
The guidance further introduces the special regulatory requirements, consultation procedure, risk assessment and performance studies with companion diagnostics. Further information can be found here.
IRELAND
HPRA process for Article 97 and notified body certificates | 13 February 2023
In December 2022, the Medical Device Coordination Group published Guidance (2022-18) on the use of Article 97 of the Medical Devices Regulation (MDR). The guidance allows for a controlled period of non-compliance for certain devices affected by the capacity challenges of notified bodies under specific conditions. Health Products Regulatory Authority (HPRA) has developed a process to use Article 97 for expiring or expired Directive certificates subject to meeting specific criteria. It will be used as a short-term measure to avoid disrupting the supply and availability of medical devices and healthcare in Ireland. Irish-based manufacturers or authorised representatives who meet the criteria can submit a request form for each certificate affected and pay the relevant fee. This process will continue until the EU Commission’s proposed legislative amendment to Article 120 of the MDR is adopted.
ITALY
Clinical trials of medicinal products and medical devices | 08 February 2023
European Regulation 536/2014 on clinical trials is fully implemented for medicinal products and medical devices. Specifically, with the Decree of the Minister of Health of 26 January 2023, subject to agreement in the State-Regions Conference, the 40 territorial Ethics Committees are identified that have the task of evaluating clinical trials on medical devices and medicines for human use, also thanks to the virtuous synergy developed between the Ministry, AIFA, Regions and Autonomous Provinces.
The Decree of the Minister of Health of 27 January 2023 also regulates the transitional phase in relation to the evaluation activities and the methods of interaction between the Coordination Centre, the territorial Ethics Committees, the Ethics Committees of national importance and the Italian Medicines Agency.
The regulatory harmonization decree was also signed, which regulates, in particular, the functions of the Ethics Committees, the criteria for the division of competences between territorial Ethics Committees and Ethics Committees of national importance, the criteria for the composition of the Ethics Committees, in order to ensure that the members are in possession of documented knowledge and experience in clinical trials of medicinal products and medical devices, also in order to guarantee its independence.
Breast implant national registry | 02 February 2023
On 2 February 2023, the Regulation establishing the National Register of Breast Prosthetic Implants, comes into force.
The National Register of Breast Prosthetic Implants feeds on data from regional registers. The Regions and Autonomous Provinces have 180 days from 2 February to establish regional and provincial registers. By 01 August 2023, the National Register of Breast Prosthetic Implants will receive data from each area of the territory.
Italy is the first country in the world that has a mandatory feeding register by surgeons who implant or remove prostheses on the national territory. Even the economic operators who distribute these devices in Italy are required to transmit the data relating to each individual breast implant marketed and intended to be implanted, both for aesthetic and reconstructive purposes.
RUSSIA
Amendment of Federal Law of the Russian Federation about advertising | 20 February 2023
Federal service for Surveillance in Healthcare (Roszdravnadzor) has amended the Federal Law of the Russian Federation dated 13.03.2006 No. 38-FZ about advertising. The law is applicable to medical devices supplied in the Russian market. The objectives of this Federal Law are:
To develop markets for goods, works and services on the basis of compliance with the principles of fair competition,
To ensure the unity of the economic space in the Russian Federation,
To exercise the right of consumers to receive conscientious and reliable advertising,
To create favourable conditions for the production and distribution of social advertising,
To prevent violations of the legislation of the Russian Federation on advertising,
To suppress the facts of improper advertising.
UNITED KINGDOM (UK)
Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU | 20 February 2023
The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The proposal recognises the challenges in capacity across notified bodies. Key changes include:
Extend the transitional period for higher-risk devices (class III and certain class IIb implantables) such as pacemakers to comply with EU MDR requirements until 31 December 2027, subject to certain conditions.
Extend the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices) such as syringes to comply with EU MDR requirements until 31 December 2028
Extend the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were valid on 26 May 2021
The UK Medicines and Healthcare products Regulatory Agency ( MHRA ) is carefully considering the implications of these revisions for the acceptance of CE-marked medical devices on the Great Britain (GB) market. At present, a device with a valid CE mark can be placed on the GB market until 30 June 2023. That would include certificates valid under the latest EU’s revised transitional arrangements if they are adopted as proposed. There are plans to extend acceptance of the CE marking in GB, but the official MHRA announcement is yet to be released.
UNITED STATES OF AMERICA (USA)
FDA Guidance on Adult Portable Bed Rail Safety | 27 February 2023
Many people use adult portable bed rails to help create a supportive and assistive sleeping environment in homes, assisted living, and residential care facilities. The guidance provides information on the risks of adult portable bed rails, recommendations for their safe use, alternatives to bed rails, and how to report medical device problems to the FDA.
Consumers can purchase many adult portable bed rails on websites and in stores without a prescription and without the recommendation of a health care provider. Adult portable bed rails marketed for medical purposes, such as those intended to assist individuals who are disabled, injured, or recovering from surgery or hospitalized with transfer in and out of bed or repositioning, intended to reduce the risk of falling or fracture or mitigate the risk of falling due to the effects of balance disorders or other medical conditions are considered medical devices regulated by the U.S. Food and Drug Administration (FDA) (see 21 CFR 890.5050 Daily activity assist device, product code, QTC Adult Portable Bed Rails for Medical Purposes).
FDA guidance on Medical Device Misconnections| 23 February 2023
FDA has recognized voluntary consensus standards for certain medical device connector designs intended to enhance device safety, such as the ISO 80369 series. Many connectors that rely on the ISO 80369 standards are currently available and incorporated into product-specific standards.
Connectors that conform to these standards are designed to help reduce the risk of medical device misconnections.
FDA guidance on Compliance Programs| 23 February 2023
FDA’s compliance programs provide guidance to FDA personnel for activities to evaluate industry compliance with the Center for Devices and Radiological Health. Some key compliance programs are available for Medical devices/Radiological health as follows:
The guidance introduces the Food and Drug Administration’s (FDA) regulatory requirements for compliance with performance standards for laser products. FDA regulates radiation-emitting electronic products, including all types of lasers products. Laser product means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product shall itself be considered a laser product. The Agency sets radiation safety product performance standards that must be met by manufacturers in order for laser products to be legally sold in the U.S. market. Laser products may fall under both the definition of a medical device and that of an electronic product, of the FD&C Act.
FDA guidance on Medical X-Ray Imaging Devices conformance with IEC standards | 21 February 2023
The guidance introduces the FDA’s policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s regulations that apply to medical devices and electronic products. In this guidance, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure efficient and consistent regulatory review of submissions for these products.
FDA guidance on Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices| 21 February 2023
This guidance document recommends 510(k) submissions for ultrasonic diathermy devices. Ultrasonic diathermy devices are devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (the FD&C Act). This includes recommendations on using International Electrotechnical Commission (IEC) standards in generating information that can support 510(k) submissions for these devices. This guidance also provides guidance on other FDA documents regarding the specific content requirements and recommendations of a premarket notification (510(k)) submission (also refer to 21 CFR 807.87). Considering the points mentioned in the guidance before submitting a 510(k) submission for such Ultrasonic diathermy devices is crucial.
AUSTRALIA
Updated guidance on Reclassification of medical devices | 28 February 2023
Therapeutic Goods Administration (TGA) has released a guide to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021, medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance of Class IIa (low-medium risk) or Class IIb (medium-high risk) devices.
This guidance is specific to medical devices composed of substances or combinations of substances intended to be introduced into the body via a body orifice or applied to and absorbed by the skin.
Updated guidance on Essential Principles-consent for non-compliance | 16 February 2023
There are Criminal Offences under section 41MA and Civil Penalties under section 41MAA of the Therapeutic Goods Act 1989 for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance.
However, extenuating circumstances may prevent compliance with one or more parts of an Essential Principle for a limited period of time.
In such circumstances, sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle. The guidance is updated with the lastest requirements for applying for consent for non-compliant products.
BRAZIL
Anvisa notification to check medical device documentation | 14 February 2023
The latest Resolution of the Collegiate Board (RDC) 751/2022 replaces the older Resolution of the Collegiate Board (RDC) 185/2001. The new standard provides for risk classification, reporting and registration regimes, labelling requirements, and instructions for the use of medical devices.
RDC 751/2022 promotes the internalization of Mercosur GMC Resolution No. 25/2021, which, at the initiative of Brazil, updated the document requirements and classification rules for medical devices applicable to the region. In addition to the internalization of the norm, the text consolidates a series of other regulations issued by Anvisa that deal with the regularization of medical devices.
Malaysia
MDA Guidance on notification of custom-made medical devices products | 01 March 2023
The Medical Device Authority of Malaysia has released a guidance to help the industry and healthcare professionals comply with the Medical Device Act (Act 737) and its regulations. The guidance provides information on the requirements of custom-made medical devices that are eligible to be exempted under the Medical Device (Exemption )Order 2016. The requirements include:
Devices must meet the criteria of the custom-made medical device, including obtaining the written prescription and specific design characteristics from a healthcare professional
Classification of the device according to the device classification as specified in the First Schedule of Medical Device Regulation 2012;
The device is safe and performs as intended.
Pakistan
Notification of Amendment in the Medical Devices Rules, 2017 | 27 February 2023
Medical devices are subject to enlistment and registration under the Drug Regulatory Authority of Pakistan (DRAP). Medical devices are exempt from enlistment and registration requirements under these rules for a period until December 2023 and 2024 under the latest amendment. These exemptions are only applicable establishment licence holders either as importer or local manufacturer if the documentation as per the amendment is available.
Figure: Enlistment and registration extension timelines under MDR,2017
Draft Amendments in the Drugs Rules 1976 and the Medical Device Rules, 2017 | 21 February 2023
The Drug Regulatory Authority of Pakistan (DRAP) has proposed to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976 and the Medical Device Rules, 2017. These draft amendments are hereby notified, seeking comments from stakeholders.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using the prescribed format via email to [email protected], or can be posted at the mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.
KUWAIT
Extension of grace period for medical device registration | February 2023
The Ministry of Health Kuwait has extended the grace period for the mandatory registration of medical devices to August 2023.
ISO Standards
List of Updated ISO standards for December 2022
ISO 11608-3:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
ISO 21649:2023 Needle-free injection systems for medical use — Requirements and test methods
ISO 5361:2023 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
IEC 80601-2- 59:2017/Amd 1:2023 Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening — Amendment 1
ISO 8600-4:2023 Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion
ISO 10943:2023 Ophthalmic instruments — Indirect ophthalmoscope
EU guidance on reference laboratories for IVD medical devices | 30 November 2022
EU Commission has published new guidance for candidate reference laboratories in the In vitro diagnostic medical devices field. The document guides laboratories planning to apply in any of the EU Member states. The key topics included are as follows:
Conformity assessment procedure for IVDs
European Union reference laboratories (EURLs) tasks
Selection procedure and designation of EURLs
Application procedure to be followed
Notified Bodies under MDR and IVDR | 21 November 2022
The 35th Notified Body, SGS Fimko Ltd, for Regulation (EU) 2017/745 on Medical Devices (MDR), has been added to the NANDO database of the European Commission. There are currently 42 Notified Bodies for Conformity Assessment and Certification under the EU Regulations on Medical Devices, including the seven listed for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MedTech report on AI Medical technologies | 02 November 2022
The event report from the recently held MedTech Europe event on ‘AI in medical technologies. Speakers from the European Commission, the medical technology sector, patient and healthcare professional representatives, and healthcare insurance discussed the benefits of AI throughout the healthcare systems. They also provided an outlook on an AI regulatory system that works for patients and promotes health innovation.
Medtech Europe Mapping of the pathways for market access to innovative medical procedures | 26 October 2022
A mapping of funding and reimbursement for medical procedures and technologies was completed by MedTech Europe and Med Tech Reimbursement Consulting (MTRC). By screening the situation in 32 European nations between July and October 2022, MTRC examined all of these pathways. The result summarises all the existing payment plans for cutting-edge medical procedures and technologies. The mapping also outlines current, practical efforts to reform healthcare systems and funding and reimbursement systems in some European nations. The report can be accessed here.
IRELAND
Guide to Clinical Investigations in Ireland | 18 November 2022
An overview of the laws governing clinical investigations (CIs) utilising medical devices is given in the guide. The manual also includes instructions on how to apply to the Health Products Regulatory Authority for permission to carry out these CIs in Ireland (HPRA). The Guidance mainly aims at CI sponsors who want to conduct CIs involving medical devices in Ireland, such as manufacturers, academic groups, and clinical research organisations.
GERMANY
Application for Authorisation of a clinical trial of Medical devices | 04 November 2022
The parties involved in conducting, authorising, or monitoring a clinical investigation or performance study (see below) may submit an application for a decision on the authorisation requirement to the higher federal authority in accordance with Section 6(3) MPDG if the regulatory classification of the planned clinical investigation or performance study cannot be clarified.
In accordance with Section 6 (3) MPDG, a non-formal application for a decision on the permission need may be filed to the BfArM. The following can apply for a clinical trial:
Sponsors of a performance study or clinical investigation
Committees for ethics (treated as competent authorities in this procedure)
Representatives of the country
Further details on the authorisation of a clinical trial of a medical device or a performance study of an in vitro diagnostic medical device can be accessed here.
UNITED KINGDOM (UK)
Updated guidance on Clinical Investigation of medical device | 21 November 2022
A clinical investigation may require a UKCA / CE /UKNI marking for medical devices. Medicines and Healthcare products Regulatory Agency has updated the guidance on clinical investigation of medical devices to include a number of filed clinical investigations in the year 2021.
Updated guidance on Clinical Investigation of medical device | 16 November 2022
Before being sold in the United Kingdom, all medical devices, including IVDs, specialised systems, and procedure packs, must be registered with the MHRA (England, Wales and Scotland). To be sold and registered with the MHRA, devices in Great Britain must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), which are in effect there.
Northern Ireland has different registration requirements. Manufacturers, UK Responsible Persons, and Authorised Representatives based in the UK or Northern Ireland are the only locations from which the MHRA will accept the registration of devices (for the Northern Ireland market). The updated guidance can be accessed here.
Guidance on Borderline products | 16 November 2022
Some products, such as those that could be medications, cosmetics, food supplements, biocidal treatments, or personal protective equipment, are difficult to differentiate from medical devices. Until their status is determined, these products are referred to as borderline products.
A product’s eligibility to be considered a medical device is determined by the MHRA, which also informs customers of their eligibility. The MHRA also decides whether a product qualifies as a drug.
The MHRA also considers the device’s risk rating and if it is appropriate for products that are medical devices. A new section, ‘Risk classification of medical devices,’ has been added to the updated guidance.
Risk classification of medical devices
The regulation outlines a system for categorising medical equipment into several risk groups. The level of assessment needed by UK Approved Bodies increases with risk.
“General” medical devices are divided into four classes under Part II of the UK Medical Devices Regulations 2002 as amended (“UK MDR 2002”).
Class I – generally regarded as low risk
Class IIa – generally regarded as lower medium risk
Class IIb – generally regarded as a higher medium risk
Class III – generally regarded as high risk
SWITZERLAND
Swissmedic to approve medical devices with FDA approval | 28 November 2022
Swiss Medtech welcomes Parliament’s instructions to the Federal Council to adapt national laws – enabling Switzerland to accept medical devices with FDA approval for the welfare of its population. Until recently, only medical devices with an EU certificate were available to patients and healthcare professionals in Switzerland. It is crucial that the order be carried out quickly and sensibly. Patient safety is important, and waiting is not an option.
Agreement with the United Kingdom on mutual recognition of conformity assessments | 17 November 2022
On November 17, Switzerland and the United Kingdom signed an agreement on the mutual recognition of conformity assessments. This means that in certain sectors, product testing by UK conformity assessment bodies is no longer required for exports from Switzerland to the UK. The agreement will go into effect by February 28, 2023, and will begin to be applied provisionally on January 1, 2023. The Federal Council approved it on November 16.
Issuance of Swiss Free Sale Certificate for medical devices | 11 November 2022
Only goods classified as medical devices under Swiss law and have a certificate of conformity, making them marketable in Switzerland, are eligible for export certifications (Free Sales Certificates, or FSC). From January 1, 2023, Manufacturers and authorised representatives based in Switzerland may request FSC export certificates from Swissmedic by submitting the necessary paperwork and the appropriate order form.
Webinar on in vitro diagnostics regulations | 10 November 2022
Swissmedic hosted an event on the new in vitro diagnostic medical devices to examine current concerns and difficulties from a regulatory perspective on November 3, 2022. The event drew 700 attendees from the diagnostics industry, medical labs, and the healthcare sector. The programme began with a presentation on Swissmedic’s role, emphasising medical devices and the consequences of the EU’s failure to update their Mutual Recognition Agreement (MRA). The event covered a variety of subjects, including advancements in IVD performance studies, stakeholder vigilance obligations, and the needs and responsibilities of healthcare institutions concerning in-house IVDs. Economic operators’ rights and responsibilities, market requirements for gadgets, and registration requirements were also covered.
UNITED STATES OF AMERICA (USA)
Updated FDA guidance on Voluntary eSTAR Program | 15 November 2022
The eSTAR is an interactive PDF form that guides applicants through preparing a comprehensive medical device submission. This form includes the following:
Automation (for example, form construction and autofill) (for example, form construction and autofill)
Content and structure that is complementary to CDRH internal review templates
Combining various resources (for example, guidances and databases)
Guided construction for every section of the submission
Automatic verification
FDA issued an updated guidance on eSTAR on 15th November.
FDA guidance on referencing the definition of ‘Device’ | 15 November 2022
Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)) contains a definition of the term “device.” The definition of “device” was changed to subsection (h)(1) and a new definition of “counterfeit device” was codified at subsection (h)(2) of section 201 of the FD&C Act as a result of the Safeguarding Therapeutics Act’s (Pub. L. 116-304) enactment.
FDA is issuing this final guidance to clarify on how it intends to interpret existing references to section 201(h) of the FD&C Act and to reference the definitions of “device” and “counterfeit device” in the future. For the benefit of FDA staff, the industry, and other stakeholders, this guidance is meant to provide clarification on the terms “device” and “counterfeit device,” as well as references to section 201(h) of the FD&C Act, in guidance, regulatory documents, and other communications and documents.
FDA Guidance on Standards and Conformity Assessment Program | 15 November 2022
The Standards and Conformity Assessment Program (S-CAP) seeks to promote patient safety, advance regulatory science, and support a least burdensome regulatory framework. By incorporating knowledge from product development, conformity assessment, and standards communities, S-CAP promotes a collaborative approach to standards development and application. This guidance document contains relevant topics such as:
FDA is also conducting a webinar on the ‘Appropriate Use of Consensus Standards’. Further details and the agenda of the meeting can be accessed here.
BRAZIL
Anvisa publishes an updated list of unregulated medical devices | 30 October 2022
National Health Surveillance Agency – Anvisa has updated its list of unregulated devices. The products that fall under this category need not be regulated under Anvisa. The list is updated regularly.
Guidance on IFU and labelling Requirements for contact lenses | 30 October 2022
The requirements applicable to the labelling and instructions for contact lenses are published in this guidance. All medical products must have an IFU in their packaging except Classes I and II, for which safe use is guaranteed without such instructions. Despite being in risk class II, contact lenses must be provided with IFUs to ensure their safety. To meet the information requirements on labels defined in the Resolution, contact lens packaging to have the following:
Instructions for use must include the mode of use, warnings and precautions to be adopted for their use, as well as instructions for cleaning and maintaining contact lenses and their cases;
The warning “SALE UNDER MEDICAL PRESCRIPTION” on the labels of contact lenses containing prescription;
The warning “USE SUBJECT TO MEDICAL PRESCRIPTION” on the labels of non-prescription contact Lenses.
AUSTRALIA
Post-market review of spinal cord stimulation (SCS) devices| 03 November 2022
The following categories of devices from the Australian Register of Therapeutic Goods (ARTG) are covered by the post-market review:
Implantable stimulation leads for the spinal cord
Implantable impulse generators for the spinal cord
Implantable stimulation leads for the peripheral spinal nerves
Implantable stimulation leads for the peripheral spinal nerves
The purpose of the review is to reassess the safety and performance of the devices, with the current real-world evidence that is now available for the intended purposes for which they are to be used.
Updated TGA guidance on consent for non-compliant devices | 23 November 2022
Import, supplying or exporting medical devices that do not meet the Essential Principles for safety and performance is a punishable offence under Criminal Offences under section 41MA and Civil Penalties under section 41MAA of the Therapeutic Goods Act 1989. However, circumstances may prevent compliance of several parts of an Essential Principle for a period of time.
In such cases, sponsors can request consent to import, supply or export such medical devices which do not conform an Essential Principle. The guidance provided contains crucial information such as applying for consent for such devices and the method to provide a submission for TGA notification.
MALAYSIA
Guidance document on Change notification for registered devices | 21 November 2022
The Medical Device Authority (MDA) created this guidance document to aid the healthcare community and the industry in adhering to the Medical Device Act’s (Act 737) regulations and requirements. The Medical Device Act 2012 (Act 737), Medical Device Regulations 2012, Medical Device (Duties and Obligations of Establishments) Regulations 2019, and Medical Device (Advertising) Regulations 2019 should be read in conjunction with this guidance document.
The categories of changes related to registered medical devices are outlined in this guidance document, along with the conditions that must be met to keep importing, exporting, or marketing medical devices.
This document covers all registered medical devices under the Act. It lays out the specific requirements a registration holder should consider when changing or modifying a registered medical device. This document only attempts to cover some conceivable combinations and types of change that might affect a medical device due to the wide range of potential outcomes.
Updated Guidance on labelling of Medical devices | 21 November 2022
Labelling is used to both identify specific medical devices and to communicate safety and performance-related information to patients or users of medical devices. Such details could be found in the use instructions, on the packaging, on the device itself or on a leaflet with patient information.
Harmonised standards for labelling would benefit the manufacturer, the user, the patient, and the regulatory authorities significantly. It is less expensive to achieve regulatory compliance and gives patients early access to new technologies and treatments when jurisdictional differences are eliminated or reduced.
MDA’s guide on the labelling of medical devices is meant to instruct manufacturers and authorised representatives on what should be included on medical device labels.
Draft Guidance on Custom-made devices | 09 November 2022
MDA has issued a draft guidance document on Custom-made medical devices. Custom-made medical devices are meant to address unique user needs when commercially available products or complementary therapies fall short of fulfilling those needs. This draft document is intended to guide the specifications of medical devices made to order that qualify for exemption under the Medical Device (Exemption) Order 2016.
CHINA
NMPA notification on Electronic Medical device registration certification | 01 November 2022
From November 1, 2022, NMPA started issuing electronic medical device registration certificates for Class II and Class III devices. The electronic certificate has the same legal effect as that of paper certificates.
NMPA Announcement on Issuing the Guidelines for QMS inspection | 01 November 2022
To efficiently inspect the quality management system for registration under the medical device registrant system and enhance the inspection quality of the quality management system for medical device registration, in accordance with the Regulations on Supervision and Administration of Medical Devices (State Council Decree No. 739), Provisions for Medical Device Registration and Filing (SAMR Decree No. 47), Provisions for In-vitro Diagnostic Device Registration and Filing (SAMR Decree No. 48), Provisions for Supervision and Administration of Medical Device Manufacturing (SAMR Decree No. 53) and other requirements. NMPA has organized to revise the Guidelines for the Inspection of the Quality Management System for Medical Device Registration
INDIA
Updated list of Medical device testing laboratories under MDR 2017 | 21 November 2022
Central Drugs Standard Control Organisation (CDSCO) has updated its list of medical device testing laboratories under the Medical device Rules,2017. The complete list of laboratories can be accessed here. The list contains the contact details, including address of lab, registration number and the scope of testing.
Updated Guidance on Form MD-41 | 18 November 2022
Central Drugs Standard Control Organisation (CDSCO) has updated user manual on on Form MD-41. The user manual contains step-by-step guidance on the application for the grant of a registration certificate to sell,stock, exhibit or offer for sale or distribution of medical devices.
