News | Malaysian Medical Device Authority Releases Guide Document MDA/GD/0063: HARMONISED BORDERLINE PRODUCTS IN ASEAN

On September 5, 2022, the Malaysian Medical Device Authority (MDA) announced the release of a guide document for the first edition of MDA/GD/0063: HARMONISED BORDERLINE PRODUCTS IN ASEAN. This document aims to assist industry and healthcare professionals in complying with relevant regulations and standards.

The guide includes information on product classification lists that differentiate between medical devices and non-medical devices based on the intended purpose as claimed by manufacturers. The first edition of this guidance document will be updated annually to incorporate the latest decisions made by the ASEAN Medical Devices Committee (AMDC).

It is important for users to read the guidance document in conjunction with current laws and regulations, specifically the 2012 Medical Devices Law (Uu 737) and the 2012 Medical Devices Regulations.

For full information, please refer to the original source from MDA Malaysia