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

USA

FDA Issues Guidance on Remanufacturing of Medical Devices

The FDA has released final guidance intended to clarify when activities performed on a medical device may be considered “remanufacturing.” The document provides criteria to help stakeholders distinguish between servicing and remanufacturing, ensuring consistent interpretation of regulatory obligations. It also outlines labeling recommendations to support the ongoing quality, safety, and performance of devices intended for servicing throughout their lifespan.

EUROPE

MDCG 2022-4 Rev. 2: Surveillance of Legacy Devices Under Article 120 MDR

Updated MDCG guidance defines expectations for “appropriate surveillance” of legacy devices covered by certificates issued under the MDD or AIMDD. Devices that did not previously require notified body involvement under the MDD but now do under the MDR are not considered legacy devices and therefore are not subject to Article 120 surveillance provisions. The document details surveillance activities for notified bodies and clarifies manufacturer obligations, including quality management system requirements.

New MDCG Templates for (Re-)Assessment Reviews

The following templates have been published:

• MDCG 2024-6 – Preliminary Re‑Assessment Review (PRAR) template (MDR) 
• MDCG 2024-7 – Preliminary Assessment Review (PAR) template (MDR) 
• MDCG 2024-8 – PAR template (IVDR) 
• MDCG 2024-9 – PRAR template (IVDR)

AUSTRALIA

Guidance Updated for Custom-Made Medical Devices

The TGA has updated guidance for custom-made medical devices, outlining responsibilities for manufacturers and sponsors, including device notifications, recordkeeping, written statements, annual reporting, inspection compliance, and advertising requirements.

Evidence Requirements for Face Masks as Medical Devices

Revised guidance details documentation and testing requirements for including face masks and respirators in the ARTG. All applications will undergo TGA audit, and sponsors are responsible for ensuring full regulatory compliance.

Updated Requirements for In-House IVDs

The revised guidance introduces a standardized notification template for Class 1–3 in‑house IVDs, instructions for completing the template, clarification of ongoing responsibilities for laboratories, and new case studies illustrating regulatory pathways for boundary and combination products.

BRAZIL

Anisa Updates Petition System for IVD Regulations

Anvisa is updating its electronic petition system to align with RDC 830/2023, covering classification, notification, registration, labeling, and IFU requirements for in vitro diagnostic devices. Some petition functions will be temporarily unavailable during the transition.

CANADA

Updated Information on the Common Electronic Submissions Gateway

Health Canada has released updated resources on the use of the Common Electronic Submissions Gateway, including guidance on eCTD and non‑eCTD formats, registration procedures, and how to submit regulatory transactions electronically.

CHINA

SFDA Issues Notice Standardizing Medical Device Classification and Definitions

A new announcement clarifies classification requirements and definitions for medical devices, strengthening regulatory consistency under several governing regulations, including the Medical Device Supervision and Administration Regulations and the IVD Registration Measures.

FRANCE

Transition to EU MDR: Key Deadline Reached

May 26, 2024 marked the deadline for manufacturers to submit certification applications under EU MDR requirements. From this date onward, devices may only be placed on the market if compliant with EU Regulation 2017/745 or if certification applications were submitted for evaluation. Between May 26 and September 26, notified bodies will review applications. After September 26, devices must have an established certification contract to continue being marketed.

AFNOR Designated as France’s Second Notified Body

On April 23, 2024, AFNOR Certification was designated as France’s second notified body under the MDR, expanding national capacity for device conformity assessment and CE marking.

HONG KONG

Guidance on the Medical Device Administrative Control System (MDACS)

Updated guidance provides an overview of the MDACS framework and details the responsibilities of Local Responsible Persons (LRPs). It also explains device, importer, manufacturer, and distributor listing procedures.

INDIA

Testing and Evaluation of Medical Devices and IVDs

India’s Ministry of Health has authorized additional testing laboratories to evaluate the safety, performance, and quality of medical devices and in vitro diagnostics, strengthening national testing capacity.

ITALY

Update on Expired MDD/AIMDD Certificates

Italy’s national database for medical devices now allows updates to expired CE certificates issued under legacy directives, resolving previous technical issues. Updates will remain available throughout the MDR transition period.

ICELAND

Marketing Authorization Submission Slots Open

Iceland has opened RMS slots for the second quarter of 2025, with updates to be provided should earlier slots become available. Slots apply to national procedures as well.

IRELAND

Guide to Clinical Investigations in Ireland

The HPRA has issued a comprehensive guide outlining legislative requirements and the submission process for clinical investigations involving medical devices. The guidance is intended primarily for sponsors but may also support ethics committees and other stakeholders.

LITHUANIA

Validity Extensions for CE Certificates

Lithuania reiterates that, under EU MDR transitional provisions, certificates for high‑risk devices are valid until December 31, 2027, and certificates for medium‑ and low‑risk devices remain valid until December 31, 2028. The rules differ depending on whether certificates expired before or after March 20, 2023.

MALAYSIA

New Circular on Trade‑Restricted Medical Devices

Malaysia’s Circular Letter No. 1/2024 requires establishments importing or exporting medical devices to or from countries lacking diplomatic relations with Malaysia to obtain approved permits (APs) before device registration. APs serve as an additional prerequisite for MDA registration applications.

SRI LANKA

Transfer of Borderline Product Dossiers

Sri Lanka’s Borderline Products Regulatory Division will accept transferred applications previously submitted under medicines, medical devices, or cosmetic categories. Applicable registration fee balances must be paid before processing.

THAILAND

FDA Exempts Government Agencies from Device Manufacturing Permission

Thailand’s FDA has opened a pathway exempting government agencies performing calibration-related device production from prior manufacturing permission. Agencies must simply submit a notification using the specified form.

UK

MHRA Updates Guidance on Compliance and Enforcement

The updated guidance outlines procedures for reporting non‑compliant medical devices, describes MHRA’s enforcement responsibilities, and explains manufacturers’ rights when enforcement notices are issued.

Updated UK Approved Bodies List

Revisions have been made to the list of UK‑approved bodies under the UK MDR 2002, including updates to LNE‑GMED UK Ltd.