Translated with AI
Interesting incentives continue for medical device manufacturers interested in expanding into the Asian market. In September 2025, the Medical Device Authority (MDA) of Malaysia officially announced that it has been recognised as an Affiliate Member of the Medical Device Single Audit Program (MDSAP).
This news marks a significant step towards harmonisation and offers international manufacturers a simplified path to access the dynamic Malaysian market.
The Role of the MDSAP Affiliate Member
The MDSAP (Medical Device Single Audit Program) is a unique international audit program that allows medical device manufacturers to undergo a single audit to verify the compliance of their Quality Management System (QMS) with the regulatory requirements of five adhering countries: Australia, Brazil, Canada, Japan, and the United States.
As an Affiliate Member, Malaysia’s MDA now accepts MDSAP reports and certificates as proof of compliance with its QMS requirements. MDSAP documentation is immediately valid in Malaysia, helping to reduce the duplication of audit or QMS evidence for:
- Pre-Market Registration: MDSAP documentation is accepted as Quality Management System (QMS) documentation for device registration applications (Pre-Market Approval).
- Establishment Licence: the reports are also valid to support Establishment Licence applications for manufacturing sites, importers, and distributors.
It should be noted that, unlike full MDSAP members (USA, Canada, Australia, Brazil, Japan), Malaysia does not have a decision-making role in the governance or future development of the MDSAP program.
Malaysia and Harmonisation Paths
Malaysia’s accession to MDSAP, along with recent cooperation agreements with Singapore and China, highlights Malaysia’s strong push towards harmonisation and simplification. This move strengthens Malaysia’s position as a strategic market for Medical Devices.
If you intend to place your device on the Malaysian market and already hold an MDSAP certification, it is the ideal time to take advantage of the program’s efficiency and accelerate the entry of your products into Malaysia.
👉 Thema can accompany your Medical Devices into the Malaysian and Southeast Asian market, in compliance with regulations. Discover the extra-EU international registration services.
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