• 2025-10-27 02:53:36

The Malaysian Medical Device Authority (MDA) has been recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP). MDA will now accept MDSAP audit reports and certificates as evidence of QMS compliance, streamlining device registration and reducing audit duplication for manufacturers.

• 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

• 2022-08-30 03:36:34

The Malaysian Medical Device Authority (MDA) issued the Fifth Edition Guidance for Labeling on Registered Medical Devices. The document's goal is to provide manufacturers and authorized representatives with a guidance on the content of medical device labelling.

• 2020-12-23 02:21:33

MDA has announced a new search database, Medical Device Authority Register (MDAR).

• 2020-02-14 07:29:47

Medical Device Authority (MDA), Malaysia has recently introduced a new initiative calling for e-mail notification subscription by all interested stakeholders. This new initiative by MDA aims to provide the latest information to stakeholders and general public who wish to subscribe to this service,