Malaysia’s Medical Device Authority (MDA) and Thailand’s Food and Drug Administration (Thai FDA) have recently signed a Confidentiality Agreement and launched a three-month regulatory reliance pilot to accelerate medical device approvals and reduce duplicate reviews in each country.
Announced in early December 2025, the pilot will run from February 1 to April 30, 2026, and cover Class B, C, and D devices. The program allows both regulators to rely on each other’s assessments to shorten timelines and improve patient access to innovative technologies.
In Malaysia, eligible Thai-approved devices may undergo an abridged review, reducing assessment timelines to 30 working days, followed by final registration within another 30 days. In Thailand, devices approved by the MDA will benefit from shorter reviews and waived expert fees. Both authorities will evaluate the pilot for possible full implementation afterward.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.