Malaysia-Thailand Launch Medical Device Regulatory Reliance Pilot To Fast-track Approvals
KUALA LUMPUR, Dec 4 (Bernama) -- Malaysia’s Medical Device Authority (MDA) and Thailand’s Food and Drug Administration (Thai FDA) have signed a Confidentiality Agreement to deepen regulatory cooperation, marking the launch of a three-month pilot programme to fast-track the registration of medical devices in both countries.
In a joint statement, both regulators said the agreement was formalised during the 29th Global Harmonization Working Party (GHWP) Annual Meeting in Bangkok Thursday.
Running from Feb 1 to April 30, 2026, the Medical Device Regulatory Reliance Pilot aims to streamline the registration of Class B, C and D medical devices by allowing both authorities to rely on each other’s regulatory assessments.
The approach is expected to reduce duplications, shorten review timelines and accelerate patient access to safe and high-quality medical technologies.
Under the pilot, MDA and Thai FDA will test simplified pathways, refine standard operating procedures, validate shorter processing timelines and collect stakeholder feedback ahead of a possible large-scale implementation.
“Medical Device Registration Certificate holders participating in the pilot can expect reduced review times in both countries,” the statement said.
In Malaysia, devices registered with the Thai FDA may undergo a verification route (abridged review) through an MDA-appointed Conformity Assessment Body, cutting the review period to 30 working days compared with 60 days under the full assessment route.
Once approved, device registration will be completed within another 30 working days.
In Thailand, devices registered with MDA may be submitted through a full submission pathway without external expert review, shortening the review period from 150 calendar days to 120 days and waiving the expert review fee.
MDA Chief Executive Dr Muralitharan Paramasua said the pilot with Thai FDA marks a significant advancement in ASEAN regulatory collaboration and supports the New Industrial Master Plan 2030 (NIMP 2030) through safer, faster and more efficient regulatory pathways.
“This initiative will attract global investment, boost regional trade and accelerate the delivery of innovative medical technologies across the region.
Building on previous reliance arrangements with China and Singapore, this partnership further demonstrates Malaysia’s commitment to strengthening regulatory systems and expanding opportunities for the medical device industry,” he said.
Thai FDA Medical Device Control Division Director Piya Chinmaneewong said the pilot represents a key milestone in regulatory cooperation and serves as a foundation for future initiatives.
“It will also function as a sandbox for ASEAN Member States in regulatory reliance. Through this pilot, we aim to reduce duplication of regulatory work, support more efficient and consistent review processes and ensure that safe, quality and high-performance medical devices reach patients in a timely manner,” he said.
Both agencies will jointly evaluate the pilot’s outcome before considering full-scale implementation.
-- BERNAMA
