FIRST EDITION GUIDANCE DOCUMENT MDA/GD/0067: POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES
This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.
The development of Guideline on Medical Device Post Market Information Exchange for ASEAN Member States was actively worked towards by Malaysia, as a member state of ASEAN. In order to further monitor post-market surveillance among ASEAN Member States, Malaysia consents to adopt this guideline following its ratification at the Twelfth Meeting of the ASEAN Medical Device Committee (AMDC), held at Bandar Seri Begawan, Brunei Darussalam, on September 12–13, 2023.
This guidance document is identical corresponding to the Guidelines on Medical Device Post Market Information Exchange for ASEAN Member States, as are to be accessed via the ASEAN website at https://asean.org.
To view the guidance document, CLICK HERE