Saudi Arabia SFDA, Announcement of Guidance on ISO 13485 Requirements and Corresponding SFDA-MDS Requirements

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 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 December 9, 22024, the Philippines FDA announced Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration under Administrative Order No. 2024-0016.  For the past 20 years, the FDA’s fees and charges were based on Administrative Order No. 50s, 2001. However, due to recent technological advancements and the development of the health products industry, ..