December 18, 2025

Malaysia’s Medical Device Authority (MDA) has taken another major step toward regulatory reliance, harmonization, and streamlined device approvals. On October 15, 2025, the MDA issued the Second Revised Circular Letter No. 2 Year 2025, together with the updated Guidance Document MDA/GD/0068 (Second Edition, September 2025).

The most impactful update:

  1.  Singapore’s Health Sciences Authority (HSA)
  2.  Thailand’s Food and Drug Administration (Thai FDA)

are now officially recognized competent authorities under Malaysia’s Conformity Assessment by Verification (CAV) framework.

This expansion significantly strengthens Malaysia’s position within ASEAN’s regulatory ecosystem and enhances reliance opportunities for manufacturers aiming for faster, smoother device entry into the Malaysian market.

Expanded List of Recognized Competent Authorities and Notified Bodies

Under the revised MDA/GD/0068, the updated list of authorities recognized for verification includes:

1.Recognized Authorities / NB for CAV:

  • EU Notified Bodies
  • Japan MHLW
  • Australia TGA
  • Health Canada
  • U.S. FDA
  • U.K. MHRA
  • Singapore HSA (new)
  • Thailand FDA (new)

This expansion represents a major move toward ASEAN convergence, enabling shorter assessment times for devices already approved in mature regulatory markets.

Revised Guidance Document MDA/GD/0070 (Second Edition, October 2025)

Alongside MDA/GD/0068, the MDA updated MDA/GD/0070 – Establishment Guide to Medical Device Registration Submission in MeDC@St through Conformity Assessment by Verification Process.

Key enhancements include:

1. Expanded Reference to HSA and Thai FDA

  • All relevant sections updated to reflect the new recognition authorities
  • Inclusion in risk-class submission pathways

2. Updated Annex 4

Annex 4 now includes:

  • Submission guidance for Class B, C, and D devices
  • Recognition of approvals from Singapore and Thailand for verification assessments

3. Process Clarifications for MeDC@St Submissions

  • Better-defined expectations for documentation
  • Standardized requirements to ensure consistent CAV evaluation

Malaysia’s 2025 Regulatory Reliance Activities: A Strengthening Network

The 2025 updates demonstrate the MDA’s ongoing commitment to reliance, collaborative assessments, and efficiency improvements.

Key Milestones in 2025

January 2025:

  • MDA announces participation in joint assessments with China’s NMPA.

July 30 – Sept 30, 2025:

  • Completion of a two-month pilot for the IVD Regulatory Reliance Program.

September 1, 2025 – February 28, 2026:

  • Implementation of the Second Malaysia–Singapore Reliance Program, reinforcing bilateral collaboration.

What This Means for Manufacturers:

  • More predictable registration timelines
  • Greater clarity in reliance procedures
  • Reduced duplication in technical evaluations
  • Faster access to the Malaysian market for devices approved by recognized authorities

Impact of the Expanded Recognition Framework

The inclusion of Singapore HSA and Thailand FDA has immediate regulatory and commercial implications.

1. Streamlined Registration for ASEAN-Approved Devices

Manufacturers with HSA- or Thai FDA-approved devices can now leverage those approvals directly in Malaysia.

2. Reduced Evaluation Time under CAV

Verification assessment becomes faster when dossiers have already been evaluated by trusted authorities.

3. Improved Regulatory Predictability

A consistent ASEAN region regulatory approach reduces administrative complexity.

4. Global Manufacturers Gain Multiple Reliance Pathways

Devices approved in the U.S., EU, Canada, Australia, U.K., Singapore, Thailand, and Japan now share a common route into Malaysia.

Technical Implications for Medical Device Establishments

Manufacturers and Authorized Representatives (ARs) should prepare for the following:

1. Updated Documentation Requirements

Ensure submission packages match the revised requirements of MDA/GD/0068 and MDA/GD/0070.

2. Harmonized Submission Dossiers

Align formatting with:

  • Singapore’s ASEAN CSDT approach
  • Thai FDA’s updated dossier structure
  • EU MDR/IVDR documentation, if applicable

3. Impact on Class B, C, and D Devices

Class C and D devices benefit significantly from reliance pathways, reducing heavy technical review duplication.

4. MeDC@St Portal Updates

Expect incremental modifications to accommodate new reliance authorities and updated form requirements.

Broader Regional Significance: Malaysia Strengthens ASEAN Regulatory Harmonization

The 2025 updates reflect ASEAN’s collective movement toward:

  • Regulatory reliance
  • Convergence of documentation
  • Improved efficiency in approvals
  • Mutual recognition ecosystems

Malaysia’s adoption of Singapore and Thailand as recognized authorities supports:

  • Cross-border regulatory collaboration
  • Accelerated market access
  • Better alignment with the ASEAN Medical Device Directive (AMDD)

Conclusion

Malaysia’s MDA continues to reinforce its commitment to regulatory reliance, efficiency, and global alignment with the release of the second revised recognition framework in 2025.

The inclusion of Singapore HSA and Thailand FDA significantly expands reliance opportunities for manufacturers while improving predictability and reducing duplication in device reviews.

These updates signal Malaysia’s strong movement toward a mature, harmonized regulatory environment—benefiting manufacturers, authorized representatives, and patients seeking timely access to safe medical technologies.

How Maven Regulatory Solutions Supports Market Entry in Malaysia

Maven Regulatory Solutions helps global manufacturers navigate Malaysia’s evolving regulatory landscape with precision and compliance.

Our Expertise Includes:

  • MeDC@St device registration support
  • CAV submission strategy and dossier preparation
  • ASEAN CSDT preparation and gap analysis
  • Regulatory intelligence for MDA updates
  • Quality system alignment for ASEAN markets
  • Liaison support with Malaysian regulatory authorities
  • Streamlined roadmap for ASEAN market expansion

Maven ensures manufacturers achieve smooth, compliant, and efficient access to the Malaysian device market.