MDA Recognized as Affiliate Member of MDSAP

Effective 16th September 2025, MDA has been officially recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP). With this recognition, MDA will now accept the MDSAP audit reports and certificates as valid evidence of compliance with Quality Management System (QMS) requirement for both establishment licensing and medical device registration.

This implementation covers two types of applications which are Establishment License Application and Medical Device Registration Application. The eligibility criteria and requirements for each are outlined below:

Application Type	Eligibility & Requirements
Establishment License Application	Local manufacturers may utilize MDSAP reports and certificates as part of the required documentation for establishment license applications; and The MDSAP audit shall be conducted by: A Conformity Assessment Body (CAB) registered with the MDA; and An MDA-registered auditor qualified to perform MDSAP audits.
Medical Device Registration Application	Local manufacturers may utilize MDSAP reports and certificates under the same conditions as for establishment license applications. Foreign manufacturers may utilize MDSAP reports and certificates issued by an MDSAP-recognized Auditing Organization as evidence of QMS compliance for the purpose of medical device registration in Malaysia.

This initiative aims to streamline regulatory processes, minimize audit duplication, and strengthen Malaysia's alignment with international regulatory standards.

 

Need Guidance on MDSAP Implementation or Malaysian QMS Compliance?
Qualtech Consulting Corporation specializes in navigating complex medical device regulations across Asia. Our experts can help you leverage MDSAP certifications to meet Malaysia's QMS requirements efficiently.
Connect with our team today to ensure compliance and accelerate your market entry.

 

References

1. 1. Recognition of the MDA as an Affiliate Member of the MDSAP and Utilization of MDSAP Reports and Certificates
2. 2. Malaysia is Now a Member of Medical Device Single Audit Program (MDSAP)