On May 1, 2026, the Medical Device Authority of Malaysia(MDA) and the Thai Food and Drug Administration(TFDA) announced the full implementation of their Medical Device Regulatory Reliance Program for Class B, C, and D medical devices.
Under the full implementation of the program, medical devices that have already obtained Thai FDA(TFDA) approval may be able to use Malaysia’s Verification Route rather than undergoing the full evaluation route. This pathway is referenced under Malaysia’s MDA/GD/0070 guidance on medical device registration submission through conformity assessment by way of verification process.
In the opposite direction, medical devices that have already obtained MDA approval in Malaysia may be able to use the MDA-Thai FDA Device Regulatory Reliance Programme in Thailand, According to the announcement, these products may bypass external expert evaluation, although a full CSDT submission is still required.
Please refer to link below.
JOINT ANNOUNCEMENT BY MEDICAL DEVICE AUTHORITY (MDA), MALAYSIA AND THAI FOOD AND DRUG ADMINISTRATION (THAI FDA), THAILAND ON 1 M
JOINT ANNOUNCEMENT BY MEDICAL DEVICE AUTHORITY (MDA), MALAYSIA AND THAI FOOD AND DRUG ADMINISTRATION (THAI FDA), THAILAND ON 1 MAY 2026 FULL IMPLEMENTATION OF THE MEDICAL DEVICE REGULATORY RELIANCE PROGRAMME BETWEEN MDA (MALAYSIA) AND THAI FDA (THAILAND) T
portal.mda.gov.my
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