Malaysia MDA and Thai FDA Announce Pilot Regulatory Reliance Program

By Amber Baade, Yu Seen Ng and Evangeline Loh

The medical device regulators in Malaysia and Thailand have announced a pilot regulatory reliance program.

Circular Letter of the MDA number 1 year 2025

The Medical Device Authority (MDA) in Malaysia released Circular Letter of the MDA, Number 2, Year 2025 (October 2025), Conformity Assessment Procedures for Medical Devices Approved by Recognised Countries. In addition, two guidance documents were revised as the second edition, MDA/GD/0068 and MDA/GD/0070.

This Circular Letter adds the Singapore HSA and Thailand FDA as approvals eligible for conformity assessment by verification, in addition to the following: EU Notified Bodies, Japan MHLW, Australia TGA, Health Canada, U.S. FDA and the UK MHRA.

MDA and Thai FDA pilot announcement

The MDA and Thai FDA announced (December 4) the pilot program (February 1- April 30, 2026) for Class B, C and D devices. 

Devices registered with the Thai FDA would be eligible for the verification route, expected to reduce the review from 60 working days (full conformity assessment) to 30 days with the Conformity Assessment Body. 

Devices authorized by the MDA would undergo the full submission pathway without the need for external expert review, which would reduce the review time from 150 calendar days to 120 days (and eliminate the expert fee).

2025 is the year of reliance for the MDA

Since January 2025, when the MDA announced its commitment to joint assessments with the China NMPA, there has been progress. The MDA and NMPA two-month IVD Regulatory Reliance Programme pilot was completed on September 30 (started July 30). A second reliance program between the MDA and Singapore HSA started September 1 (ending February 28, 2026). Now this reliance pilot between the MDA and Thai FDA is set to begin.

Concluding remarks

As part of this announcement, Dr. Paramasua, Chief Executive, MDA, stated that this “represents a paradigm shift in ASEAN regulatory collaboration, supporting the New Industrial Master Plan 2030 (NIMP 2030) by enhancing patient safety, reducing time-to-market, and improving regulatory public service excellence.” And, Mr. Chinmaneewong, Director of Medical Device Control Division, Thai FDA stated this is “a sandbox for ASEAN Member States in regulatory reliance.” 

The MDA continues to demonstrate its commitment to regulatory reliance and to support the development of such initiatives among the ASEAN members.