Malaysia becomes an affiliate member of MDSAP

[2025-09-19] (Open Access) Malaysia’s Medical Device Authority (MDA) announced its recognition as an affiliate member of the Medical Device Single Audit Programme(MDSAP) via its website on September 19, 2025.

For the record:

The MDSAP is a unique audit program designed to verify the compliance of a company’s Quality Management System (QMS) with the regulatory requirements of several countries. The requirements of the MDSAP standard are those of ISO 13485, supplemented by those specific to the member countries of the program. Manufacturers wishing to be certified to the MDSAP standard must use an auditing organization (AO) recognized by MDSAP.

The international partners taking part in MDSAP include:

• Members of the MDSAP or “RAC” (Regulatory Authority Council): United States, Canada, Australia, Japan and Brazil;
• Official MDSAP observers: the World Health Organization (WHO), the European Union, the Medicines & Healthcare products Regulatory Agency (MHRA) and Singapore’s Health Sciences Authority (HSA);
• Affiliate members: Argentina, South Korea, Israel, Kenya, Mexico, Taiwan, South Africa and Malaysia.

To learn more about the roles and responsibilities of affiliate members, you can read this document updated on April 1st, 2025.

As an affiliate member, Malaysia may use MDSAP audit reports and/or MDSAP certificates to assess a medical device manufacturer’s QMS under its own regulations for pre-market authorizations (device registration applications) and establishment licenses (for manufacturers, importers and distributors), under certain conditions specified on the MDA website on September 25, 2025.

Malaysian manufacturers with audit reports and/or MDSAP certificates are now able to access a wider global market.

Conclusion

The MDSAP program continues to expand, reinforcing international regulatory convergence. Malaysia’s accession as an affiliate member now facilitates access to its market for manufacturers already holding MDSAP certificates.

Article written by Lam-Xé NOEL, Managing Director of DM Experts SAS