Malaysia MDA Announces Second Update to Policy on Recognition

Amber Baade and Evangeline Loh

MDA circular letter 

The Medical Device Authority (MDA) in Malaysia revised the Circular Letter of the MDA Number 2 Year 2014 titled Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries in March 2025. The March document was titled Circular Letter of the MDA Number 1 Year 2025. Two guidance documents accompanied this: MDA/GD/0068 and MDA/GD/0070.

Both Circular Letter of the MDA Number 1 Year 2025 and MDA/GD/068 on guidance for Conformity Assessment Bodies (CAB) performing verification assessments (in contrast to full conformity assessment) included a table which described the recognized approvals issued by Recognized Competent Authorities: EU Notified Bodies, Japan MHLW, Australia TGA, Health Canada, U.S. FDA, and U.K. MHRA.

Recognition and verification review

Circular Letter of the MDA Number 1 Year 2025 explains recognition: “acceptances of conformity assessment or market placement approval of medical devices in certain countries,” “prevent a repetition process,” “reduce costs and accelerate the registration of medical devices in this country,” and “facilitate the conformity assessment process, which is through verification of the compliance evidence.”

MDA reliance activities in 2025

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

From the MDA review perspective, devices that meet the program’s conditions would be eligible for the verification assessment, reducing review times from 60 working days to 30 working days.  

Revised MDA circular letter 

The MDA revised and issued (Oct. 15, 2025) the Circular Letter of the MDA Number 2 Year 2025, effective Sept. 30, 2025. In addition, MDA/GD/0068 was revised (second edition, September 2025). 

Guidance changes are described in the Revision History Table 2. The condition to have “marketed for at least one year in the respective agencies’ jurisdictions” was removed.

Addition of recognized countries

Circular Letter of the MDA Number 2 Year 2025 expands the list of recognized countries to include the Singapore HSA and the Thailand FDA (Table 5). 

Concluding remarks

The MDA continues to demonstrate its commitment to regulatory reliance and to advancing access to medical devices authorized by recognized countries.

Emergo by UL applauds global medical device regulatory efficiency and all appropriate uses of regulatory reliance.