On 19 September 2025, the Medical Device Authority (MDA) of Malaysia announced that Malaysia has officially become an Affiliate Member of the Medical Device Single Audit Program (MDSAP). This significant milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device regulatory framework.
Scope
The announcement marks Malaysia’s formal recognition as an Affiliate Member of MDSAP. It underscores Malaysia’s commitment to harmonizing with international regulatory standards and enhancing the efficiency of its medical device oversight.
Key Highlights
Recognition
- The Medical Device Authority (MDA) Malaysia has been officially recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP).
Acceptance of MDSAP Documentation
- The MDSAP Report & Certificate will now be accepted by MDA as part of the Quality Management System (QMS) documentation required for:
- Pre-Market Approval (device registration applications)
- Establishment Licence (for manufacturers, importers, distributors)
For more information on this regulation, please refer to the link provided earlier in this document: MALAYSIA IS NOW A MEMBER OF MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP).
Key Takeaways
- MDA’s acceptance of MDSAP audit reports and certificates integrates Malaysia into a globally recognized regulatory framework.
- This may help streamline regulatory submissions and reduce duplicative audit or QMS evidence.
- Malaysian manufacturers with MDSAP are now positioned for broader global market access as audit outcomes will be more widely accepted.
Implications for Clients
- Medical device manufacturers and Authorized Representatives can now submit MDSAP audit reports and certificates as part of their pre-market registration submissions with MDA for both device registration and establishment licences.
- The MDSAP report will be accepted by MDA as part of the required Quality Management System (QMS) documentation.
- Global market access benefit: Malaysian manufacturers with MDSAP are likely to have their audit outcomes more broadly accepted, since Malaysia is now an affiliate member of MDSAP.
Effective Date
This announcement is effective immediately upon publication by the Medical Device Authority (MDA).
Next Steps
Should you have any inquiries regarding this announcement, please don’t hesitate to reach out to us. You can contact our team at sales@andamanmed.com or click the button below for more details.
