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..

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 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..

On January 24, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea established the guideline for the approval and review of standalone digital medical device software utilizing usability in accordance with the implementation of the Digital Medical Products Act.  The guideline was created to clearly explain the scope and criteria for usability evaluation when approving or reviewing standal..

On January 6, 2025, the Central Drugs Standard Control Organistion (CDSCO) of India released a draft updating on existing risk-based medical device classification list. This update includes reclassification and new classifications for the following categories:1. Interventional Radiology2. Radiotherapy3. Oncology4. Class A (Non-Sterile and Non-measuring) medical devices The updated guideline in I..

On December 17, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a partial revision of the medical device standard specifications. The revision was made to align with international standards, aiming to enhance the safety and quality levels of medical devices distributed domestically and to prevent potential health risks to the public.  The revisions made to align the medic..

December 13, 2024, The Therapeutic Goods Administration (TGA) of Australia has announced the publication of the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.3) 2024, which reflects transitional measures for IVD products. This determination allows manufacturers to register IVD products in Australia to meet product regist..