Thailand FDA, announces new guidelines for the notification of changes in In Vitro Diagnostic (IVD) medical devices

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 December 16, 2024, the Indonesian Ministry of Health (MoH) issued a regulation (FR.03.01/E.V/2672/2024) classifying Dried Blood Spot (DBS) products as medical devices.  This regulation refers to the classification of DBS as a medical device under the U.S. FDA’s CFR 21 and follows Law No. 17 of 2023 on Health, Article 143, which mandates that the supply of pharmaceuticals, medical devices, and..