EUROPEAN UNION (EU)
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.
Due to this amendment, there were many queries raised regarding the new transitional periods under MDR. The latest guidance has been developed taking into account the objectives pursued by the amendment with a view to making the best use of the additional time provided by the extension of the MDR transitional period.
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.
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.
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.
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
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.
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
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.
The guidelines can be accessed below:
- Guidelines on Dental Adhesive Product Registration
- Guidelines on Artificial Shoulder Prostheses Registration
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.
China NMPA Provides Relief for Cosmetic Industry with Eased Ingredient Safety Information Submission Policies | 29 March 2023
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
China SAMR to Implement Administrative Measures on Toothpaste: Notification Mandatory for All Toothpastes | 24 March 2023
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
On March 17, 2023, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Research on Freckle-removing and Whitening Cosmetics (the “Guidelines for Whitening Cosmetics”) and the draft Technical Guidelines for Research on Functional Ingredients of Freckle-removing and Whitening Cosmetics (the “Guidelines for Whitening Ingredients”) for public consultation.
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.
CSAR Subsidiary Regulations: China Implements the Strictest Cosmetic Sampling Testing Regulation | 08 March 2023
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.
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
List of Updated ISO standards for March 2023
- BS EN ISO 8536-15:2022+A1:2023 Infusion equipment for medical use. Light-protective infusion sets for single use
- BS ISO 29782:2022 Prostheses and orthoses. Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
- BS EN 80601-2-59:2017+A1:2023 Amendment 1. Medical electrical equipment. Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.