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July Newsletter 2022


Harmonised administrative practices and alternative technical solutions| 13 July 2022

The MDCG guidance document advises the Member States and other relevant parties on applying specific IVDR regulations in the absence of Eudamed. This guidance defines harmonised administrative processes and alternative technology alternatives for information interchange until Eudamed is entirely operational. Based on the appropriate provisions of Directive 98/79/EC, this guidance covers specific instances when information exchange would be difficult, if impossible, to execute.

Implementation of Regulation (EU) 2022/1107 for common specifications under Regulation (EU) 2017/746| 5 July 2022

The European Commission has established common standards for high-risk diagnostics, including HIV tests and SARS-CoV-2 assays. The guidelines establish uniform and stringent criteria for tests across the EU, clarifying the requirements for market participants and protecting EU patients. Annexes I to XIII of EU Regulation 2022/1107 specify the various standards to be met by Class D in vitro diagnostic medical devices in terms of performance characteristics. Annex XIII defines the standards for devices that detect or quantify markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The EU Regulation 2022/1107 can be accessed here.


Webinar on “CLV of cosmetic products – procedures and critical issues”| 11 July 2022

An online event titled “CLV of cosmetic products – procedures and critical issues” is organised by the Directorate General for Medical Devices and Pharmaceutical Service – DGDMF (Office 8) and is targeted at businesses in the industry interested in applying for Certificates of Free Sale (CLV) for “export of cosmetic products.” To know more on the topic, click here.


Updated Guidance on Registering Medical devices in UK| 28 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on medical device registration in the UK. The guidance now contains a specific Coronavirus Test Device Approval (CTDA) section. Persons planning to supply, put into service, or place a coronavirus test device on the UK market must apply for clearance from the UK’s Health Security Agency (UKHSA).

The MHRA will not accept registration applications for covid test devices until they have received Coronavirus Test Device Approval (CTDA) or are placed on the Temporary Protocol list.

Over 285,000 medical devices and medicines seized in UK | 20 July 2022

In the latest press release by the Medicines and Healthcare products Regulatory Agency (MHRA), over 285,000 illegal drugs and medical devices were seized. The MHRA have seized large quantities of illegally traded medicines and medical devices in an Interpol week of action known as “Operation Pangea”.

Over £850,000 in medicines and medical devices, totalling over 285,000 items, have been seized by officers from the UK’s MHRA as part of a global operation to combat the illegal sale of medical products, with UK seizures estimated to be worth around 9% of the global total.

Guidance on Innovation Accelerator | 26 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the Innovation accelerator, which aims to provide access to MHRA’s scientific expertise, regulatory assistance, and enhanced advice and signposting service for inventors and developers of novel products. It provides regulatory information, advice, and guidance to organisations of all sizes and backgrounds based in the UK or globally (industry, academics and patient groups).

The Innovation Office is open to queries from those developing innovative medicines, medical devices, manufacturing processes and blood components for transfusion.

Public consultation on future regulation of medical devices | 26 June 2022

MHRA has released a document on the future regulation of medical devices in the UK by MHRA. The document contains feedback from a wide demographic, including healthcare professionals and manufacturers. The highlights of this document include:

  • Possible reclassification of medical devices increased post-market surveillance of medical devices
  • Implementation of improved traceability of medical devices
  • Government to introduce Alternative market routes
  • Rescheduled CE marked devices acceptance and UKCA dates.


New EUDAMED information Center launched | 21 July 2022

The European Commission has launched the new EUDAMED Information Center. It combines all EUDAMED Production User Guides, offers rapid and organised access to all relevant information, and includes a contact form for users to contact the EUDAMED Support Team. For more information, click here.

MedTech Europe Survey Report on MDR implementation| 20 July 2022

MedTech Europe performed a study with 475 responses from major and small businesses to quantify medical device availability. According to the findings, less than 15% of medical equipment has previously gained MDR certification. The time to certification has increased to 13-18 months, and more than 15% of SMEs still do not have access to an MDR-designated Notified Body. As a result, over half of respondents believe they will deprioritise the EU market for new device regulatory approval. The report discusses how MDR implementation will affect the EU medical device market.

Swissmedic information sheet on in-vitro diagnostic device notifications | 14 July 2022

Swissmedic has released an updated document on in vitro diagnostic medical devices. The information sheet answers some of the frequently asked questions on IVD notification. The document contains information on when the notification form for IVDs must be submitted, the timeline for processing the application and other important information.


Unique Device Identification system: Communications and stakeholder engagement| 18 July 2022

The success of the UDI system needs to involve health professionals, healthcare organisations, consumers, and industry in its creation and implementation. The TGA will interact and consult with stakeholders to ensure that all viewpoints, notably those of medical device users, are considered. The TGA’s public reporting will guarantee that the TGA’s progress toward establishing the UDI system is transparent. Click here to access the latest webinar on UDI implementation.

Safety information on home use fetal dopplers (heartbeat monitor) | 07 July 2022

The TGA is now studying foetal cardiac monitors’ safety indicators, advantages, and disadvantages for home use. This review is shared with consumers and healthcare professionals. The TGA’s examinations will help assess whether utilising these gadgets carries more risk than the potential benefit.

Fetal dopplers are handheld devices that track the foetal heart rate between 10 and 12 weeks of pregnancy. Traditionally, health workers have employed these tools in clinical settings. Fetal dopplers for home usage have become readily accessible recently, and users don’t need special training to use them. The TGA is aware of instances in which Fetal dopplers for home use have led to patients receiving delayed medical care and false reassurance. The Royal Australian and New Zealand College of Obstetricians and Gynecologists and the US Food and Drug Administration (US FDA) have released guidelines on using these monitors. Both do not encourage the usage of home doppler equipment to detect the foetal heartbeat.


Patient Labelling Recommendations for Laser-Assisted In Situ Keratomileusis (LASIK) Lasers | 27 July 2022

The content and formatting for patient labelling information for laser-assisted in situ keratomileusis (LASIK) devices are recommended in this guidance document. This guidance is to help ensure that both physicians and patients understand the benefits and dangers of these devices. The recommendations are issued in response to concerns that some patients are not receiving or understanding information about the benefits and hazards of LASIK equipment. The labelling suggestions mentioned in the document are meant to supplement, not replace, physician-patient discussions about the advantages and dangers of LASIK devices that are unique to patients.

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices | 22 July 2022

In this guidance, the FDA modified the Global Unique Device Identification Database (GUDID) submission requirements for several class I devices considered consumer health goods. In particular, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices requiring a UDI on their labels and device packages because they are deemed consumer health items. Furthermore, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, before December 8, 2022, regardless of whether they are consumer health products (an additional 75 calendar days).

Medical Device Types for Section 506J Notification Obligation | 19 July 2022

FDA has updated the guidance containing suggestions based on the device types and corresponding product codes for manufacturers when they are required to notify FDA during the COVID-19 pandemic under section 506J. Section 506J of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of specific devices that leads to a disruption in the supply of that device in the United States.

FDA has listed the device types and their corresponding product codes so that manufacturers can consider whether they are required to notify FDA during the COVID-19 pandemic under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Tracking Premarket Submission’s Progress (Progress Tracker) | 18 July 2022

The Center for Devices and Radiological Health’s (CDRH) progress in assessing Traditional, Abbreviated, and Special 510(k) applications is tracked by the FDA using a secure, web-based tracker. Official Correspondent can now track the FDA’s progress online when you submit a 510(k) submission to CDRH for review in a clear, concise manner.

The FDA provides online progress tracking to uphold its obligations under the Medical Device User Fee Act (MDUFA). The application tracker can be accessed here.

510(k) Third Party Review Organization Performance Report for FY22 – Q3| 8 July 2022

The FDA Modernization Act of 1997 (FDAMA) established the Accredited Persons Program to enhance the effectiveness and timeliness of the FDA’s 510(k) procedure. As part of the programme, the FDA accredits Third Parties (Accredited Persons) qualified to perform the initial 510(k) reviews for admissible devices.

In accordance with MDUFA (Medical Device User Fee Act) IV, the FDA committed to publicly making online the performance of each accredited Third Party with at least five successfully submitted documents (e.g., the specific number of holds and the typical turnaround time for decisions). Every quarter, a summary of Third-Party Performance Metrics will be published. Data from FY 2018, Q1 through FY 2022, and Q3 are included in this study (October 1, 2017, through June 30, 2022). The report can be accessed here.


Health reform decree to simplify the registration of low-risk processed foods and cosmetics| 06 July 2022

The sanitary registration of processed foods and low-risk cosmetics will be made easier by an amendment to executive decree 43291-S. The operation, which formerly took 30 days to complete, must be finished immediately. According to Minister of Health Joselyn Chacón Madrigal, the purpose of this kind of reform is to make the nation more competitive to draw investment and facilitate business through digital governance. The list of cosmetic items has also been expanded to include items for the face (moisturising creams, masks, and powders), mouthwash, and alcohol solution for hand cleansing.


Bahrain Health Regulatory Conference on 27-29 September 2022| 26 June 2022

The National Health Regulatory Authority (NHRA) will hold Bahrain’s 2nd Health Regulatory Conference. Government healthcare decision makers, health reform and regulation experts, pharmaceutical and drug company owners, public and private healthcare providers, investors and interested experts in the healthcare business, technology experts, solution providers, and healthcare professionals will all be present at the exhibition. The exhibition will take place from 27th -29th September 2022.

This is an opportunity to exchange knowledge and thoughts while participating in an educational platform.


China approves new domestically developed ‘artificial heart’| 17 July 2022

“Artificial heart” for severe heart failure developed in China has received commercial permission from the NMPA of China.

The TEDA International Cardiovascular Hospital and the China Academy of Launch Vehicle Technology collaborated to develop the artificial heart; they have been researching the third generation of ventricular assist devices in China since 2009.

According to the Annual Report on Cardiovascular Health and Diseases in China (2021), published in late June, there are 8.9 million heart failure patients in China. According to the report, 58 of the 68 medical devices that the NMPA authorised to join its “innovative medical device evaluation channel” between September 2020 and August 2021 were Chinese.


Full enforcement of medical devices regulations 2019 from July 2022| 01 July 2022

Malaysia’s Medical Device Authority (MDA) has announced that the Medical Devices Regulations 2019 will be implemented entirely from July 1, 2022.

With full enforcement of this Regulation, all parties involved in the importation, distribution, and placement of medical devices on the market are required to comply with all of the requirements set out in this Regulation, which generally set out post-market control requirements, such as complaint handling, mandatory problem reporting, corrective and preventive actions in the field (field corrective action) and recall for medical devices. Further information regarding labelling can be found here.


Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs | 01 July 2022

An updated version of the Regulatory Guidelines for Laboratory Developed Tests (LDTs) has been made available by the Medical Devices Cluster (MDC) for stakeholder consultation. Under the Healthcare Services Act, clinical laboratories are currently subject to MOH regulation and licencing (HCSA). Considering the present regulatory requirements that apply to clinical laboratories under HCSA, the regulatory approach for LDTs will be based on the current regulatory standards applicable to commercial in-vitro diagnostic devices (IVDs).

The document provides an overview of the scope of LDTs and the regulatory requirements applicable, including Product controls, Manufacturing Quality controls and Post-market controls.


Health Science Council Pharmaceuticals and Medical Devices System Subcommittee to be held on 05 August 2022| 22 July 2022

A Subcommittee will be held on the 5th  of August 2022. The agenda includes:

  • Discussions on the revised Pharmaceuticals and Medical Devices Act
  • Working group on the work of pharmacists and the functions of pharmacies
  • Others relevant topics

Study Group on Early Introduction of Medical Devices with High Medical Needs will be Held | 20 July 2022

This study group aims to identify in-vitro diagnostic medications and medical devices with significant unmet medical requirements that are not licenced or indicated in Japan and to consider their fast introduction into clinical practice.


Notice regarding non-notified medical devices | 11 July 2022

According to notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices in the Class A and Class B categories are expected to enter the licencing regime by October 1, 2022. For Class A and Class B medical devices, a transition period of 30 months from the date of introduction of G.S.R. 102(E), i.e., 01.04.2020, has been provided for the transfer to the licencing regime.

In the notice, CDSCO strongly recommends that all manufacturers apply for a manufacturing licence for Class A and Class B medical devices using CDSCO’s online portal so that the manufacturing licence can be obtained from the various State Licensing Authorities following a review of the applications and audit.

Classification of medical devices pertaining to Rehabilitation under Medical Device Rule 2017| 06 July 2022

The requirements of the Drugs and Cosmetics Act of 1940 govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules (MDR) for regulating medical devices in import, production, clinical evaluation, sale, and distribution, following consultation with the Drugs Technical Advisory Board. The updated list of medical devices under MDR includes acupressure calf band and Arthritis TENS system, among other medical devices that aid rehabilitation. The complete list of medical devices and the product class can be accessed here.

Please note: Always refer to the regulations in the respective ministry of health website for authorised news and releases.

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