MALAYSIA: Updated in Conformity Assessment Body (CAB) and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment By Way of Verification (MDA/GD/0068) and (MDA/GD/0070) – September/October 2025

• 2025-10-27 03:24:28

The Malaysia Medical Device Authority (MDA) has published the latest Conformity Assessment Body (CAB) guide and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment by Way of Verification process, which includes updates on additional recognized regulatory authorities and revised verification procedures to help establishments streamline registration and ensure regulatory compliance.

More

THAILAND: Medical Device Categories Applicable for Full CSDT Submission and Partial 2 Submission Route – January/February 2023

• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

More