ARQonJul 15, 20221 minPhilippines: Requirement of CMDR and CMDN start period amended from 1 April 2022 to 1 April 2023 Section V (1) of FC No. 2021-002-A is hereby amended as follows: The date when all Class B, C, and D medical devices that are already in...
ARQonJul 15, 20221 minPhilippines: FDA publishes new draft for IVD regulators (Jan 2022) In January 2022, the Philippines FDA published a new draft regulation on IVD market authorization. The draft was open for public review...
ARQonJun 24, 20222 minMalaysia: Guideline Re-registration of registered medical device Section 5 (1) of Medical Device Act 2012 (Act 737) requires a medical device to be certified under the Act before it can be ferried,...
ARQonJun 24, 20221 minSingapore: HSA provides risk classification tool as guidance on MD grouping Effective from 2022, HSA would no longer accept service request from manufacturers requiring affirmation of their classification and...