The Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) have officially announced the successful completion of the three-month pilot phase that ran from 1 February 2026 to 30 April 2026. Following this successful completion of the Medical Device Regulatory Reliance Programme pilot between MDA and Thai FDA, both regulatory authorities have agreed to move forward with the full implementation of the programme for the registration of Class B, Class C, and Class D medical devices.
Regulatory Procedures Under the Full Implementation
Upon the full implementation of the MDA–Thai FDA Medical Device Regulatory Reliance Programme, both authorities have outlined the procedures will be applied moving forward:
| MDA (Malaysia) | Thai FDA (Thailand) | |
| Implementation | Any medical devices that have obtained Thai FDA (Thailand) approval can bypass the full evaluation route by utilizing Verification Route | Any medical devices that have obtained MDA (Malaysia) approval can bypass the external expert evaluation with full CSDT submission |
| Reference | MDA/GD/0070: Establishment Guide to Medical Device Registration Submission in MeDC@St through Conformity Assessment by way of Verification Process. | (Draft) Notification of the Thai Food and Drug Administration Re: List of Reference Agencies Recognized by the Thai Food and Drug Administration for Inspection or Certification of Medical Devices or Medical Devices Establishments |
Market Impact and Regulatory Significance
Through the implementation of this reliance programme, both the MDA and the Thai FDA can reduce regulatory duplication, accelerate market access, and improve patient access to quality healthcare technologies. This streamlined approach provides a faster route and lower cost to market while maintaining safety and performance standards through enhanced regulatory and administrative efficiency.
As the MDA–Thai FDA reliance programme expands to Class B, C and D medical devices, medical device companies may wish to further monitor its potential impact on future ASEAN regulatory strategies. For further discussion, please feel free to Contact us. Qualtech Malaysian experts based in Selangor remain available to exchange local perspectives where relevant.
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