mda_thaifda

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)

The Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) of Thailand signed a Confidentiality Agreement to deepen regulatory cooperation and officially launched a 3-month pilot of the Medical Device Regulatory Reliance Programme as part of the agreement. The signing took place during 29th GHWP Annual Meeting held in Bangkok, Thailand on 4 December 2025.

Following the successful completion of the three-month pilot phase (1 February 2026 to 30 April 2026), MDA and Thai FDA are pleased to announce the full implementation of the MDA – Thai FDA Medical Device Regulatory Reliance Programme for the registration of Class B, C, and D medical devices.

1. Successful Pilot Outcomes

The pilot phase successfully demonstrated that the reliance model significantly optimizes the registration process for Class B, C, and D medical devices by leveraging the regulatory reviews of a trusted partner. By utilizing approval from MDA and Thai FDA, both authorities were able to reduce regulatory duplication, accelerate market access, and improve patient access to quality healthcare technologies. This streamlined approach provided a faster route to market while simultaneously ensuring safety, upholding rigorous performance standards through increased administrative efficiency.

The success of the initiative is further evidenced by the supportive participation of industry stakeholders in this pilot project, establishing a proof-of-concept for the reliance model and its future full implementation.

2. Transition to Full Implementation

Effective immediately, the program moves from a pilot status to full implementation of the MDA – Thai FDA Medical Device Regulatory Reliance Programme. This transition marks a permanent shift toward regulatory harmonization between Malaysia and Thailand, streamlining the market entry process for medical device manufacturers in both territories.

Under this MDA – Thai FDA Medical Device Regulatory Reliance Programme, the following procedure may be applied:

a) MDA (Malaysia) Verification Route

  • Reference: MDA/GD/0070: Establishment Guide to Medical Device Registration Submission in MeDC@St through Conformity Assessment by way of Verification Process.
  • Note: Any medical devices that have obtained Thai FDA (Thailand) approval can bypass the full evaluation route by utilizing this Verification Route, significantly streamlining the local registration process.

b) Thai FDA (Thailand) MDA – Thai FDA Medical Device Regulatory Reliance Programme

  • Reference:
    - Press release of the MDA – Thai FDA Medical Device Regulatory Reliance Programme
    - (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
  • Note: Any medical devices that have obtained MDA (Malaysia) approval can bypass the external expert evaluation with full CSDT submission, significantly streamlining the local registration process.

3. Strategic Commitment

 This full implementation reinforces the commitment of both nations and strengthens the regional medical device ecosystem, according to the WHO Good Reliance Practices. By facilitating smoother market access, Malaysia and Thailand aim to remain at the forefront of medical innovation, ensuring that healthcare providers and patients have timely access to high-quality medical technologies.

Medical Device Authority (MDA) of Malaysia

For technical questions on registration, please email: registration@mda.gov.my

Thai Food and Drug Administration (Thai FDA) of Thailand
For media queries, please email: inter.mdcd@gmail.com

 

1 May 2026