Andaman Medical Regulatory Affairs Update Malaysia

Malaysia: MDA Releases Guidance Document MDA/GD/0067: Enhancing Post Market Information Exchange for ASEAN Member States

The Medical Device Authority (MDA) has released Guidance Document MDA/GD/0067, First Edition, titled “Post Market Information Exchange for ASEAN Member States“, to assist the industry and healthcare professionals in complying with the Medical Device Act (Act 737) and its associated regulations.

The development of the Guideline on Medical Device Post Market Information Exchange for ASEAN Member States was actively pursued by Malaysia as an ASEAN member state. Malaysia has officially adopted this guideline to enhance the monitoring of post-market surveillance among ASEAN Member States. The adoption took place following its ratification at the Twelfth Meeting of the ASEAN Medical Device Committee (AMDC) held in Bandar Seri Begawan, Brunei Darussalam, on September 12–13, 2023.

The MDA/GD/0067 roughly consists of the following information:

  • Requirements on exchange of post market information;
  • Events leading or highly likely to lead to unanticipated public health threat;
  • Observations from national trend analysis;
  • Request and / or share of information;
  • Annexes consist of the Reporting Template and instructions for filling up the reporting template form.

For information on the newly issued regulation can be accessed here: MEDICAL DEVICE POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES (mda.gov.my)

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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