The Medical Device Authority (MDA) of Malaysia announced that Malaysia has been officially recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) by the MDSAP Regulatory Authority Council (RAC), effective September 16, 2025.
This milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device regulatory framework.
To read the full announcement: Recognition of the MDA as an Affiliate Member of MDSAP and Utilization of MDSAP Reports and Certificates
Key Highlights
- The MDA has been recognized as an Affiliate Member of the MDSAP.
- MDSAP Reports and Certificates will now be accepted by MDA as evidence of compliance with Quality Management System (QMS) requirements for regulatory submissions.
- These may be used in support of both establishment licensing and medical device registration applications.
Application Type | Eligibility & Requirements |
Establishment License Application |
1) A Conformity Assessment Body (CAB) registered with the MDA; and 2) An MDA-registered auditor qualified to perform MDSAP audits. |
Medical Device Registration Application |
|
For more information on this regulation, please refer to the link provided earlier in this document.
Effective Date
September 16, 2025
Implications to the Client
- Local manufacturers in Malaysia may now use MDSAP certificates and reports in place of ISO 13485 for both establishment license and device registration applications (subject to meeting MDA eligibility requirements).
- Foreign manufacturers may submit MDSAP certificates and reports from MDSAP-recognized Auditing Organizations as QMS evidence for device registration in Malaysia.
- Important Note: Outside Malaysia, acceptance of MDSAP certificates will depend on whether the target market is also a member of MDSAP.
Contact us at sales@andamanmed.com for guidance, or click the button below for support in Malaysia.
