The Medical Device Authority in Malaysia Releases Second Revised Guidance on Expanded Recognition Framework

Yu Seen Ng and Evangeline Loh

Circular Letter of the MDA No. 2 Year 2025 and the revised Guidance Document MDA/GD/0068

As reported by Emergo by UL, the Medical Device Authority (MDA) in Malaysia revised and issued (Oct. 15, 2025) Circular Letter of the MDA Number 2 Year 2025, effective Sept. 30, 2025, and the guidance document MDA/GD/0068 (second edition (September 2025)). The most significant change was the expansion of the list of recognized countries.

Singapore and Thailand are now recognized competent authorities 

The Singapore HSA and Thailand FDA have been added to the table of approvals eligible for conformity assessment by verification: EU Notified Bodies, Ministry of Health, Labour and Welfare of Japan (MHLW), Therapeutic Goods Administration of Australia (TGA), Health Canada, U.S. Food and Drug Administration (FDA) and U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

The complete list of recognized regulatory authorities or notified bodies: EU Notified Bodies, Japan MHLW, Australia TGA, Health Canada, U.S. FDA, U.K. MHRA, Singapore HSA and Thailand FDA (Table 5, Appendix 1, MDA/GD/0068).  

Guidance document MDA/GD/0070 has also been revised

The accompanying guidance Document, MDA/GD/0070, was also revised to the second edition (October 2025). This guidance is titled Establishment Guide to Medical Device Registration Submission in MeDC@St through Conformity Assessment by Way of Verification Process. 

References to Singapore HSA and Thailand FDA have now been added, including in Annex 4, Submission guide for Class B, C and D.

MDA reliance activities in 2025

The MDA adds this expansion of recognized competent authorities to its list of activities in 2025.

• January 2025, MDA announced its commitment to joint assessments with the China NMPA
• July 30, two-month IVD Regulatory Reliance Programme pilot, completed on Sept. 30
• Sept. 1, second reliance program between the MDA and Singapore HSA, ending Feb. 28, 2026

Concluding remarks

The MDA continues to demonstrate its commitment to regulatory reliance and to advance the access of medical devices in Malaysia when authorized by recognized countries.

Emergo by UL continues to celebrate global medical device regulatory efficiency and all appropriate cases of regulatory reliance.