LOGO_25_SEPTEMBER_2025.jpeg

 

ANNOUNCEMENT UPDATE

 

Recognition of the Medical Device Authority (MDA) as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) and Utilization of MDSAP Reports and Certificates

 

Dear All Medical Device Industry Stakeholders,

The Medical Device Authority (MDA) extends its highest regards to all valued stakeholders.

This announcement serves to inform the industry that the MDA has been officially recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) by the MDSAP Regulatory Authority Council (RAC) effective 16 September 2025, following the recent official announcement published by MDA. This achievement marks an important milestone in strengthening Malaysia’s medical device regulatory system by aligning with global best practices and greater reliance on internationally recognized audit programs.

With this recognition, MDA will begin accepting MDSAP reports and certificates to support regulatory submissions for establishment licensing and medical device registration as evidence of compliance with Quality Management System (QMS) requirements.

Implementation Scope

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, 

·         The MDSAP audit shall be conducted by:

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

·        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 enhance regulatory efficiency, reduce duplication of audits, and facilitate faster market access while maintaining high standards of safety, quality, and performance for medical devices in Malaysia.

Thank you.

 

For further information and inquiries, please contact:

Pre-Market Control Division

Medical Device Authority (MDA)

Ministry of Health (MoH)

Level 5, Prima 9 (Block 3547)

Prima Avenue II, Persiaran APEC

63000 Cyberjaya, Selangor Darul Ehsan

            Date: 25th September 2025

Pre-Market Control Division I [email protected] I [email protected]

 

For PDF version, please CLICK HERE.

 

Date uploaded: 25 September 2025

Prepared by: Pre-Market Control Division

Uploaded by: Corporate Communication Division