December 25, 2025
The Medical Device Authority (MDA) of Malaysia has issued a significant update to its recognition and reliance policy, reinforcing the country’s commitment to regulatory efficiency and harmonization with regional and global authorities. The Circular Letter of the MDA Number 2 Year 2025, released on October 15, 2025, introduces structural revisions, expanded recognized authorities, and adjustments to verification assessment conditions that directly impact medical device manufacturers seeking Malaysian market authorization.
Maven Regulatory Solutions provides the following detailed analysis of the regulatory updates and their implications for manufacturers preparing for the 2025–2026 submission cycle.
1. Background: Evolution of Malaysia’s Recognition and Verification System
Malaysia’s recognition framework allows the MDA to accept conformity assessments and approvals issued by trusted international regulatory authorities, reducing duplication, review times, and cost burdens for manufacturers.
In March 2025, the MDA reissued the foundational circular, now titled:
Circular Letter of the MDA Number 1 Year 2025, accompanied by
• MDA/GD/0068 – Guidance for Conformity Assessment Bodies conducting verification assessments
• MDA/GD/0070 – Additional implementation guidance
These documents outlined the conditions and process for verification assessments (as opposed to full conformity assessment), referencing recognized approvals from:
- EU Notified Bodies
- Japan MHLW
- Australia TGA
- Health Canada
- U.S. FDA
- U.K. MHRA
The goal remains consistent: adopt a reliance-based framework that avoids repetitive assessment and accelerates registration.
2. Recognition Framework Explained: Purpose and Regulatory Intent
The updated Circular Letter describes recognition as the acceptance of conformity assessments or market placement approvals from specific countries too:
• Prevent redundant evaluation processes
• Reduce regulatory complexity
• Accelerate medical device market entry in Malaysia
• Support reliance through verification of documented compliance evidence
This reaffirms Malaysia’s position as one of the fastest-evolving reliance-driven regulatory systems in the Asia-Pacific region.
3. Expansion of MDA Reliance Activities in 2025
Malaysia’s regulatory reliance strategy expanded substantially in 2025.
3.1 China NMPA Joint Assessments
In January 2025, MDA formalized its commitment to collaborative reviews with the China NMPA.
A two-month IVD Regulatory Reliance Program pilot (July 30 – September 30) demonstrated the feasibility of synchronized regulatory review mechanisms.
3.2 Singapore HSA Reliance Program
A second reliance program with Singapore HSA began on September 1, 2025, ending February 28, 2026.
Devices meeting the eligibility criteria reviewed under the verification pathway, reducing timelines from:
• 60 working days → 30 working days
This marks one of the most significant review-time reductions for the region.
4. The October 2025 Policy Revision: Circular Letter of the MDA Number 2 Year 2025
The updated circular (effective September 30, 2025) introduces key revisions, accompanied by the Second Edition of MDA/GD/0068 (September 2025).
Changes documented in Revision History Table 2.
Key Policy Change
The previous condition requiring devices to market for at least one year in the recognized authority’s jurisdiction removed.
This enables earlier reliance on eligibility, significantly benefiting newly approved high technology, digital health, AI-enabled, and IVD devices.
5. Expansion of Recognized Countries (Table 5)
The updated Circular Letter expands the recognized authorities list to include:
• Singapore Health Sciences Authority (HSA)
• Thailand FDA
These additions strengthen regional alignment within ASEAN and support the broader trend toward mutual reliance and harmonization.
The complete recognized authority set now includes:
EU NB, Japan MHLW, Australia TGA, Health Canada, U.S. FDA, U.K. MHRA, Singapore HSA, and Thailand FDA.
This expanded list enhances opportunities for rapid Malaysian market access and increases regulatory predictability.
6. Strategic Implications for Manufacturers
Manufacturers planning Malaysian submissions should consider the following implications:
- Faster time-to-market through expanded eligibility for verification pathways.
- Earlier submission opportunities due to removal of the one-year market presence requirement.
- Broader acceptance of approvals from ASEAN collaborates (Singapore and Thailand).
- Streamlined documentation requirements under updated MDA/GD/0068.
- Optimized regulatory planning for devices recently authorized in recognized markets.
- Reduced administrative effort via reliance rather than full conformity assessment.
- Better predictability for global regulatory strategy, particularly for manufacturers executing multiregional rollouts.
Conclusion
Malaysia’s updated recognition and reliance framework strengthens its position as an agile and collaborative regulator in the Asia-Pacific region. The MDA has expanded list of recognized countries, elimination of legacy constraints, and continued reliance on pilots demonstrate a modern, efficiency-driven regulatory strategy.
Maven Regulatory Solutions supports manufacturers in navigating these updated pathways, optimizing verification submissions, and ensuring full compliance with the revised Circular Letters and guidance documents.
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