[News Brief] Malaysia and Thailand Launch Medical Device Regulatory Reliance Pilot

Malaysia and Thailand Launch Medical Device Regulatory Reliance Pilot

The Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (FDA) have initiated a three-month pilot programme to accelerate cross-border medical device registration.

  • Streamlined Process: The pilot allows both regulators to rely on each other’s technical assessments for Class B, C, and D medical devices to reduce duplicate reviews.
  • Timeline: The programme is scheduled to run from 1 February 2026 to 30 April 2026, targeting faster market entry for innovative technologies.
  • Efficiency: In Malaysia, Thai-approved devices may see review times halved to 30 working days, while Thailand will waive certain expert fees for MDA-registered products.

This summary is based on a report by Andaman Medical.

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