Malaysia and Thailand Fully Implement Medical Device Regulatory Reliance Program

On May 1, 2026, Malaysia’s Medical Device Authority (MDA) and Thailand’s Food and Drug Administration (Thai FDA) officially launched the full implementation of their Medical Device Regulatory Reliance Program following a successful pilot phase conducted from February 1 to April 30, 2026.

Applicable to Class B, C, and D medical devices, the initiative is expected to streamline medical device registration in Malaysia and Thailand while advancing ASEAN medical device regulation through greater regulatory reliance and harmonization.

From Pilot Project to Full Implementation

The initiative stems from a Confidentiality Agreement signed by MDA and Thai FDA during the 29th Global Harmonization Working Party (GHWP) Annual Meeting in Bangkok in December 2025.

To assess the practical application of regulatory reliance, both authorities conducted a three-month pilot program. The results demonstrated that assessments performed by one regulator could be effectively leveraged by the other while maintaining regulatory oversight and public health protections.

Following the pilot's success, MDA and Thai FDA agreed to fully implement the program. Aligned with the internationally recognized Good Reliance Practices (GRelP), the initiative reflects a broader global trend toward reliance-based regulatory frameworks and positions Malaysia and Thailand at the forefront of regulatory convergence within ASEAN.

How the Malaysia–Thailand Medical Device Reliance Pathway Works

The program establishes reciprocal pathways that allow manufacturers to leverage approvals already granted by one authority when seeking registration in the other market.

While each regulator retains responsibility for its final decision, eligible products may benefit from streamlined review procedures that reduce duplicate assessments and administrative burden.

Malaysia: Verification Route for Thai FDA-Approved Devices

Medical devices that have obtained Thai FDA approval may utilize Malaysia’s Verification Route for medical device registration. Under this pathway, applicants may bypass the full evaluation route, reducing duplicated regulatory review and streamlining the registration process.

The requirements for this route are outlined in “MDA/GD/0070 – Guide for Establishment Medical Device Registration Submission Guide for Conformity Assessment by Way of Verification Process and Submission of Application in MeDC@St,” which establishes the framework for verification-based assessments of eligible medical devices.

Thailand: Reliance Pathway for MDA-Approved Devices

Medical devices that have already received MDA approval may utilize Thailand’s reliance pathway.

As described in the “Press Release of the MDA–Thai FDA Medical Device Regulatory Reliance Program,” applicants may bypass external expert evaluation while continuing to submit the required Common Submission Dossier Template (CSDT) documentation. This approach reduces review complexity and supports a more efficient registration process in Thailand.

The pathway is further supported by the 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 Device Establishments,” which includes MDA among the reference agencies recognized by Thai FDA for reliance-based reviews.

How Manufacturers Can Strengthen Southeast Asia Market Access Strategies

As reliance-based frameworks gain traction across ASEAN, manufacturers still face critical strategic decisions — where to initiate filings, how to sequence registrations, and when an existing approval can be leveraged for cross-market entry. In this shifting environment, regulatory strategy plays a defining role.

Turning these frameworks into practical execution often requires support across multiple steps, including identifying reliance eligibility, structuring an optimal registration sequence, preparing submissions, and coordinating with regulatory authorities throughout the region. Cisema works with manufacturers to translate these requirements into actionable strategies that support efficient, compliant market access.

Planning registrations in Malaysia, Thailand, or across Southeast Asia? Contact Cisema to identify the most efficient pathway for your products.

Further Information

• Explore Cisema’s medical device services for Malaysia.
• Discover Cisema’s medical device services for Thailand. 

References

• Joint Announcement by Medical Device Authority (MDA) Malaysia and Thai Food and Drug Administration (Thai FDA) Thailand, May 1, 2026  ‍
• SECOND EDITION GUIDANCE DOCUMENT MDA/GD/0070: Guide for Establishment Medical Device Registration Submission Guide for Conformity Assessment by Way of Verification Process and Submission of Application in MeDC@St  ‍
• (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 Device Establishments