Malaysia’s Regulatory Modernization with MDSAP and Streamlined Guidance

In a powerful display of commitment to global harmonization and regulatory efficiency, Malaysia’s Medical Device Authority (MDA) has recently announced two major advancements for the MedTech industry.

1. Global Trust Achieved: Malaysia Joins the Medical Device Single Audit Program (MDSAP)

On 19 September 2025, Malaysia officially became a member of the Medical Device Single Audit Program (MDSAP). This is a historic milestone that immediately elevates the MDA’s regulatory framework to a globally recognized standard.

The Impact of MDSAP Membership:

The core benefit is clear: qualified manufacturers who undergo a single MDSAP audit can now leverage the resulting audit reports and certificates as part of their pre-market approval submission process with the MDA.

This transition is expected to yield multiple benefits:

• Accelerated Market Access: It reduces duplicative audits and accelerates review timelines, translating to faster availability of safe medical innovations for Malaysian patients.

  
  

• Enhanced Regulatory Credibility: It reinforces Malaysia's position as a globally trusted authority, aligning its standards with those of major regulatory bodies like the U.S. FDA, Health Canada, and Australia's TGA.

  
  

• Optimized Global Processes: Manufacturers can simplify their Quality Management System (QMS) audit strategy, saving time and resources that would otherwise be spent on country-specific requirements.

2. Operationalizing Efficiency: New Guidance on the Verification Process (MDA/GD/0070)

Complementing the high-level MDSAP agreement, the MDA has also released the Second Edition Guidance Document MDA/GD/0070. This guide provides the crucial, ground-level instructions that make regulatory efficiencies a reality.

This updated document serves as a comprehensive guide for local manufacturers and Authorized Representatives on two key areas:

• Registration by Verification (Abridged Process): The guide details the Conformity Assessment by way of the Verification Process. This abridged route allows manufacturers to rely on regulatory approvals obtained from recognized overseas countries, a principle similar to the mutual reliance seen in the recent Singapore-Malaysia pilot.

  
  

• Centralized Submission: It provides instructions for submitting applications for medical device registration and conformity assessment through the Medical Device Centralised Online System (MeDC@St).

By issuing this updated guidance, the MDA is providing the practical tools necessary to operationalize a faster, more streamlined submission process for the industry.

The Combined Message

Malaysia’s dual focus on joining the internationally recognized MDSAP program and updating local guidance to support abridged submission routes signals a strong commitment to regulatory excellence and cooperation.

For MedTech companies, the key takeaway is that the pathway to market in Malaysia is becoming clearer, more harmonized, and more efficient. Companies must, however, ensure their MDSAP certificates are valid and carefully review the new MDA/GD/0070 guidance to align their documentation for these new, faster submission routes.

This is a significant, positive leap forward that strengthens the medical device landscape across Southeast Asia.

Source: Medical Device Authority (MDA), Malaysia