Malaysia, Thailand implement MedTech reliance program

Agencies in Malaysia and Thailand have implemented a regulatory reliance program for medical devices after a successful three-month pilot.

Malaysia’s Medical Device Authority (MDA) and the Thai Food and Drug Administration (Thai FDA) signed a confidentiality agreement to deepen collaboration in December 2025. The agencies piloted the medical device reliance program from February to April 2026. Having completed the pilot, the agencies have transitioned to the full implementation of the program.

Effective immediately, companies that have received Thai FDA approval for a medical device can use MDA’s verification process to bring the product to market in Malaysia. Bypassing the full evaluation route streamlines the regulatory process in Malaysia. The conformity assessment process takes about 1.5 months, after which MDA requires 14 to 30 working days to review the paperwork, depending on the class of medical device.

The Thai FDA has set up an equivalent program. Any devices approved in Malaysia can bypass the external expert evaluation with the full common submission dossier template filing. MDA said bypassing that step significantly streamlines the local registration process. The program strengthens the regional medical device ecosystem and supports timely access to medical devices in both countries, MDA said.

During the pilot, the reliance model significantly optimized the registration process for Class B, C, and D medical devices by leveraging the regulatory reviews of a trusted partner, MDA said. MDA and the Thai FDA reduced regulatory duplication, accelerated medical device launches, and improved patient access to healthcare technologies, according to the Malaysian regulator.

The program provided a streamlined path to market “while simultaneously ensuring safety, upholding rigorous performance standards through increased administrative efficiency,” MDA said. The agency cited the “supportive participation of industry stakeholders” in the pilot as evidence of the success of the initiative.

Transitioning to full implementation continues MDA’s expansion of its reliance program. In recent months, Singapore’s Health Sciences Authority and the Thai FDA have joined bodies in Australia, Canada, the European Union, Japan, the UK, and the US on the list of regulatory authorities or notified bodies recognized by MDA. RAPS.org