In accordance with Good Reliance Practice, the Thai FDA and Malaysia MDA have jointly established the Malaysia MDA – Thai FDA Pilot Project that enables registration approval granted from one country to shorten the medical device registration timeline in the other. This bilateral initiative aims to promote cross-border exports between Thailand and Malaysia, simplify medical device registration procedures, reduce regulatory burden, and minimize costs and time-to-market for manufacturers.

 

Effective Time Period

This pilot project is effective from February 2026 until 30 April 2026.

 

Eligibility Criteria

To qualify for this fast-track registration route, the following conditions must be met:

1. Risk Classification

Medical devices must be classified as Class 2–4 (Thai FDA) or Class B–D (Malaysia MDA).

*Class 1 or A devices are not eligible under this pilot program.

2. Valid Malaysia MDA Approval

A valid approval certificate from Malaysia MDA is a prerequisite for proceeding with this medical device reliance program.

3. Regulatory Consistency

The trade name, models/ identifiers, intended use, indications, and device labeling must be identical to that approved by Malaysia MDA.

4. Exception

Devices exempted from safety, efficiency, and performance assessment by Malaysia MDA (Exempted Product Approval) are not eligible.

 

Document Requirements for Submission

• Full Common Submission Dossier Template (Full CSDT) –  identical to the dossier submitted to Malaysia MDA
• Proof of registration approval from Malaysia MDA

 

Reciprocal Recognition

The Malaysia MDA – Thai FDA Pilot Project is a bilaterzal initiative that allows both authorities to recognize each other's approvals, eliminating the need for companies to repeat the same registration process twice. Manufacturers with Thai FDA approval can also apply through Malaysia MDA's Verification Route

 

Conclusion

The Thai FDA and Malaysia MDA have established a mutual recognition pilot project, enabling approvals from one country to accelerate medical device registration in the other to simplifies the registration process and promote medical device trade between Thailand and Malaysia.

Benefits of the Malaysia MDA-Thai FDA Pilot Project

✔ Shortened review timeline

✔ Reduced regulatory duplication

✔ Lower costs

✔ Accelerated ASEAN market entry

✔ Increased trade between Thailand and Malaysia

 

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References:

Official Thai FDA website: Malaysia MDA - Thai FDA Pilot Project