DECEMBER 2023 REGULATORY OVERVIEW

BY MEDTECH CONSULTING- A SUBSIDIARY OF UNIVERSAL THERAPEUTICS

MALAYSIA

Updates to Guidance Documents on Harmonised Medical Device Classification and Borderline Products in ASEAN

12th December 2023

The Medical Device Authority (MDA) has released updated editions of two Guidance Documents, namely the Harmonised Classification of Medical Devices in ASEAN (MDA/GD/0062) and Harmonised Borderline Products in ASEAN (MDA/GD/0063). These revisions are in accordance with the latest decisions of the ASEAN Medical Device Committee (AMDC).

MDA/GD/0062 Harmonised Classification of Medical Devices

The second and latest edition includes additional medical device classification categories, commencing from the "Cardiovascular Devices" category on page 12 through page 19 of the guidance document.

MDA/GD/0063 Harmonised Borderline Products in ASEAN

Twenty-four new products have been incorporated into the list of borderline medical devices with medicine, spanning from item no. 181 to 204.

The original MDA announcements can be accessed

here and here. For further enquiries, please contact us at our contact form here.

SINGAPORE

None for the month of December.