Medical Devices – USA, Europe, Asia and ROW Regulatory News – Apr 2024

USA

FDA Data Standards Catalog Version 10.3

The FDA Data Standards Catalog listed the submission data standards for dependent properties i.e., technical document.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog

EUROPE

MDCG 2024-5 – guidance on content of the Investigator’s Brochure for clinical investigations of medical devices

The IB shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. The information shall be presented in a concise, simple, objective, balanced, and non-promotional form that enables a potential investigator and the investigation site team, to understand it and make his/her own unbiased benefit-risk analysis of the appropriateness of exposing study participants to the investigational device. Further the IB should contain sufficient information to allow safe and correct use of the device.

The document is intended to support sponsors in developing their IB by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application. The guidance is based on the requirements of both the MDR and ISO14155:2020 as well as experience from the competent authorities.

MDCG 2022-9 / Rev.1 – Summary of safety and performance Template

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).

The SSP should include information dedicated to the intended user, and if relevant, the patient. The SSP shall be kept updated in Eudamed. If the device is not intended for self-testing, the SSP should be dedicated to the professional user. If the device is intended for self-testing, the SSP should be written in a way that is clear to the patients/lay persons, for instance taking into consideration the age of the targeted population.

MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746

Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR). The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in IVDR Article 69

For post-market performance follow-up (PMPF) studies of CE marked devices1 used within the intended purpose covered by the CE marking, reporting requirements of IVDR Articles 76(5-6) apply. This means that the vigilance provisions laid down in IVDR Articles 82 to 85 and in the acts adopted pursuant to IVDR Article 86 apply to PMPF studies.

A Study and dashboard on reprocessing and reuse of single-use-devices in the EU

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) – through the European Health and Digital Executive Agency (HaDEA) – commissioned a “Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market

The study started in December 2022 and was performed over 14 months. It was contracted to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Civic Consulting, S&P Global and Areté). The study main objective is to evaluate how the provisions established in the MDR have been implemented in European countries and how such provisions operate.

CHINA

Notice on the public solicitation of opinions and suggestions on “Guiding Principles for Registration and Review of Laparoscopic Surgery Systems Part 5: Systems and Software”

This review point applies to multiport laparoscopic surgery systems (referred to as surgical systems). According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 01-07-03, and the management category is Class III.

The key points of this review are general requirements for laparoscopic surgery system products. The registration applicant should determine whether the content is applicable based on the specific characteristics of the product. If it is not applicable, the reasons and corresponding scientific basis must be explained in detail, and based on the product’s Specific characteristics will enrich and refine the content of the registration application materials.

FINLAND

The EU Parliament approved the proposed changes to the MD and IVD regulations

The amendment decree introduces new obligations to provide advance information related to the availability of devices to the authorities when the interruptions in the availability of the device or the end of production are estimated to cause significant disruptions to healthcare. 

The changes regarding the transitional periods of the IVD Regulation are related to the additional time given to manufacturers for the application of the new regulation. The new transition periods depend on the type of device and especially the risk category according to the IVD Regulation.

Manufacturer of medical devices – make sure to take advantage of the extension of the transition period

The Medical Device Regulation (EU) 2017/745 (MD Regulation) allows the manufacture of devices in accordance with previous directives for a long time, but only under certain conditions.

Fimea reminds manufacturers of medical devices again that the application to the notified institution must be submitted no later than May 26, 2024. Unless an application has been submitted, there is no return to the use of further transition periods, and the manufacture of the device must be stopped until compliance is demonstrated in accordance with the MD Regulation.

GERMANY

Request for classification and/or delimitation

For a delimitation or classification decision by the BfArM, an informal application for classification and/or delimitation must be submitted to the BfArM in accordance with Section 6 Paragraph 2 of the Medical Devices Law Implementation Act (MPDG). In principle, a notified body, the manufacturer, its authorized representative or the responsible state authority are entitled to apply.

The delimitation of a product is based on the definition of medical devices in Article 2 No. 1 of Regulation (EU) 2017/745 (Medical Device Regulation, MDR). The classification is carried out according to the classification rules of Annex VIII of the MDR.

Incident reporting by manufacturer and authorized representatives

Until the European database for medical devices is fully functional in accordance with Article 33 of Regulation (EU) 2017/745 (MDR), the reporting form below must be used

• Reports of serious incidents in accordance with Article 87 MDR by manufacturers (for medical devices excluding in-vitro diagnostics)
• Reports of serious incidents in accordance with Article 82 of Regulation (EU) 2017/746 – IVDR (for in-vitro diagnostics)

HONG KONG

The Medical Device Information System (MDIS) is supporting New Applications for listing Medical Devices and Traders

The Medical Device Division has introduced a new Medical Device Information System (MDIS) on 2 April 2024, which will offer a one-stop e-service for the industry to submit online applications for listing of medical devices (MDs) and traders under the Medical Device Administrative Control System (MDACS), as well as to report safety alerts and adverse events related to MDs.

https://www.mdd.gov.hk/en/mdacs/mdis/index.html

Application for the Listing of Class II/III/IV General Medical Devices (MD101)

Medical Device Administrative Control System Application for the Listing of Class II/III/IV General Medical Devices

https://www.mdd.gov.hk/filemanager/common/useful-information/Form_MD101e.pdf

Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) (MD102)

Medical Device Administrative Control System Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD)

https://www.mdd.gov.hk/filemanager/common/useful-information/Form_MD102e.pdf

Application for Inclusion on the List of Importers / Distributors (MD-IP+D)

Medical Device Administrative Control System – Application for Inclusion on the List of Importers/ Distributors

https://www.mdd.gov.hk/filemanager/common/useful-information/md_ip_d.pdf

https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf

HUNGARY

Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

From 31 January 2025 onwards sponsors are requested to transition to the legal framework of the CTR the ongoing clinical trials that are currently under the regime of the Clinical Trials Directive (CTD) and expected to be ongoing after 30 January 2025.

PORTUGAL

Publication of Decree-Law No. 29/2024, which ensures the implementation, in the Portuguese legal order, of Regulation (EU) 2017/745, relating to medical devices

The diploma establishes, among others, a set of rules applicable to economic operators and health institutions that manufacture and use devices in their respective facilities, as well as rules relating to the use and traceability of devices, the designation and supervision of the activities of notified bodies and market surveillance and inspection.

The diploma also defines the conditions and requirements that the reprocessing and use of reprocessed single-use devices must comply with in national territory, with the aim of establishing the necessary safety and performance conditions of the devices.

PHILIPPINES

Reminder on the Submission of Financial Reports in the FDA Online Disclosure Reporting System

Pursuant to Section 35(b) of RA No. 11223 on Ethics in Public Health Policy and Practice, all FDA-licensed manufacturers, traders, repackers, distributor-importers, and distributor- wholesalers of drug, medical devices, and biological products, including vaccines, and medical supplies registered with the FDA are mandated to collect and track all financial relationships with healthcare providers and healthcare professionals and report these to the Department of Health, through the FDA.

Since the release of Department of Health Administrative Order No. 2021-0036, the FDA has outlined guidelines and established an Online Disclosure Reporting System (ODRS). This system enables stakeholders to conveniently submit all financial relationship disclosure reports.

SAUDI ARABIA

Update: Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use

The updates in this version are as follows:

• Create a new email to receive application Hajj@sfda.gov.sa
• Change the email to Hajj@sfda.gov.sa
• Applications will be received via External Hajj Unified System of the Ministry of Hajj.

SOUTH KOREA

Announcement of partial revision of the “Enforcement Rules of the In Vitro Diagnostic Medical Devices Act”

The Act stipulates matters necessary for handling, management, and support, such as manufacturing and importing in vitro diagnostic medical devices, to ensure the safety and quality improvement of in vitro diagnostic medical devices, and to enhance the international competitiveness of in vitro diagnostic medical devices. The purpose is to contribute to the improvement of national health and the development of in vitro diagnostic medical devices by strengthening it.

SPAIN

The AEMPS participates in the European action JAMS 2.0 to carry out joint inspections of medical devices

The Spanish Agency for Medicines and Health Products (AEMPS) participates in the JAMS 2.0 joint action, framed within the EU4Health program of the European Commission, which aims to improve European coordination, surveillance and control of the health products market and medical devices for in vitro diagnosis. The Agency is part of four of the eight work packages of this initiative and is the leader of one of them, work package 7 (WP7) to develop a common methodology for the implementation of European campaigns. market control.

These inspections will be carried out by teams made up of inspectors from several EU countries, together with those from the country where the economic operator is located. AEMPS inspectors will participate in several of these joint inspections. 

SRILANKA

Informed to the Local agent regarding the email confirmation process for the foreign manufacturing site application

All importers of Medical Devices are hereby informed that NMRA will terminate the email confirmation process for the foreign manufacturing site application (FMSA). Hence, you can submit FMSA application without the email confirmation which is issued by the Head of Medical Device Division/NMRA with effect from 22nd of April 2024.

This applies for pending email confirmations as well.

SWITZERLAND

Information sheet Medical Device Software

The information sheet is intended for manufacturers/developers of medical device software and for economic operators (importers, distributors, authorised representatives) in the distribution chain for such devices.

THAILAND

FDA reduces time for requesting permission Emphasis on difficulty and ease according to the risks of medical device products

The FDA has adjusted the system for making changes to facilitate medical device operators through the online system, leaving only 15 business days for hassle-free requests for changes. Not complicated medical equipment Ready to develop work on medical device product supervision and effective consumer protection.

Pharmacist Lertchai Lertwut, Deputy Secretary-General of the Food and Drug Administration, revealed that the Food and Drug Administration (FDA) has opened a channel through the E – submission system to facilitate entrepreneurs applying for minor changes. change which is a type of change that is not difficult or complicated, such as editing the manufacturer of medical equipment, editing the name and address of the product owner, editing the name of the manufacturer in a foreign country without changing the location, etc.

FDA recommends checking for sure in 3 ways before using medical device products

The FDA recommends 3 channels for consumers to check medical device products that have been approved by the FDA by checking the registration number or taking a photo of the product before receiving service. for safety

Deputy Secretary-General of the FDA added that for manufacturers, importers, and sellers of medical devices that are not approved by the FDA, there is a penalty of imprisonment not exceeding 2 years or a fine not exceeding 200, 000 baht, or both. If consumers find suspicious or unauthorized products You can report it at the FDA hotline 1556, P.O.F., Ministry of Public Health, Nonthaburi Province 11004 or Provincial Public Health Offices nationwide.

UNITED KINGDOM

Guidance: Notify MHRA about a clinical investigation for a medical

To carry out a clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI marking for your medical device. must inform the MHRA is there any planning to do clinical investigation at least 60 days before starting your investigation. Applications are submitted electronically using the Integrated Research Application System (IRAS). A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.

Update: Guidance on Borderlines with medical devices and other products in Great Britain

The guidance document only covers borderline products with general medical devices as specified in Part II of the Medical Device Regulations 2002 (as amended), and therefore does not cover borderlines with in-vitro diagnostic medical devices or active implantable medical devices. The guidance is specific to products conforming to the UKCA marking requirements unless otherwise stated. The document helps that the product is considered to be a medical device under UK legislation.