On Mar 18, 2025, the European Commission (EC) published the revised guidance on classification rules for In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, under MDCG 2020-16 rev.4.  The purpose of this document is to provide guidance to manufacturers, Notified Bodies (NB), and healthcare institutions on how to classify In Vitro Diagnostic Medical Devices before placing them on..

On March 25, 2025, a guidance document was issued to provide compliance instructions on ISO 13485:2016 Medical Devices-Quality Management System-Requirements (ISO 13485) for medical device manufacturers, authorized representatives, importers, and distributors, considering the regulatory documents issued by the Saudi Food and Drug Authority (SFDA) Medical Devices Sector (MDS).  Manufacturers, imp..

To import, distribute, and supply medical devices in the Malaysia market, compliance with the requirements of the Medical Device Act 2012 (Act 737), including medical device registration, is required.  However, if medical devices need to be imported and re-exported for purposes such as maintenance, testing, sterilization, packaging, labeling, distribution hurbs, or other purposes designated by t..

On March 11, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a public notice regarding the partial revision of the standards for medical device manufacturing and quality control. This revision aims to allow domestic export companies to undergo both KGMP and Medical Device Single Audit Program (MDSAP) simultaneously.  The revision provides a legal basis for combining the ‘MDS..

On February 28, 2025, the Enforcement Rule of the Digital Medical Products Act was established to define the delegated matters and necessary implementation details following the enactment of the Digital Medical Products Act (effective January 24, 2025) and its Enforcement Decree (effective January 24, 2025).The key provisions of the Enforcement Rule include:1) Specific criteria for the classific..

On February 3, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced new guidance on Digital Mental Health Technologies (DMHT) due to the increasing use of mental health apps, AI-based assessments, virtual reality therapies, and other digital mental health technologies. This new guidance is aimed at manufacturers.  The guidance document helps manufacturers identify th..

The Korean Ministry of Food and Drug Safety (MFDS) has clarified the scope of medical devices subject to cybersecurity requirements during the medical device approval and review process. It has also defined the applicable security requirements and the range of materials that must be submitted based on the product’s characteristics to ensure the safety management of communicable medical devices. ..

On February 10, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a partial amendment to the “Regulation on Medical Device Groups and Class by Group”. The amendment introduces new subgroups for items that were previously managed under broader groups or require clear classification systems for safety management. The aim is to improve the efficiency of medical device safety mana..

On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) announced new guidelines regarding the change notification process for In Vitro Diagnostic (IVD) medical devices.  1. Addition of Medical Device Items:The application of change for the addition of medical device items is categorized into one of the following four cases: Case 1). Addition of Medical Device Items - When adding r..

On January 31, 2025, the Medical Device Authority (MDA) of Malaysia issued the 2nd edition of the guidelines (MDA/GD/0065) to guide companies on the requirements for pre-market, placement in the market and post-market activities for HIV self-testing kits (HIVST) in the Malaysian market.  The key updated contents of the guidelines are as follows: 1) Regulatory requirements for facilities handling..