Thai FDA now accepts Malaysia MDA medical device approvals under the reliance programme

What the notice says

On 8 October 2026 Thai FDA posted No. 2 (B.E. 2569) of its notification listing foreign authorities whose medical device assessments or certifications it accepts. It adds Malaysia's Medical Device Authority (MDA) as entry 8 in the annex to the 2024 (B.E. 2567) notification. The notice is dated 6 October and takes effect immediately ("ทั้งนี้ ตั้งแต่บัดนี้เป็นต้นไป"). Its legal basis is Section 35, paragraph 2 of the Medical Device Act B.E. 2551.

Acceptance comes with two conditions:

• The device must be approved or registered by MDA under the MDA–Thai FDA Medical Device Regulatory Reliance Program. Devices that MDA approved through a route exempt from safety and performance evaluation are excluded.
• The intended use, indications, labeling, instructions for use and packaging submitted in Thailand must be the same as those MDA approved.

Business implications

Manufacturers already registered in Malaysia through this programme can now point to MDA's assessment when applying for a Thai licence or notification. Start by checking which route your Malaysian registration came through. Registrations granted any other way, including evaluation-exempt routes, fall outside this recognition.

The second condition is the harder one in practice. If you changed label wording, the IFU or packaging specifically for Thailand, your documents no longer match the MDA-approved set. The notice does not say whether adding Thai-language text still counts as "the same". Line up your Thai submission against the MDA-approved documents item by item before filing. The notice also does not say how much review time or documentation the recognition saves.