New Regulatory Documentation Exemptions in Thailand

On March 12th, 2024, the Thai FDA released draft guidance stating their intention to update the list of required documentation for Full and Concise Evaluation. For manufacturers registering qualifying medical devices in Thailand, certain documents will no longer required. Thailand has three regulatory pathways:

1. Full Evaluation (CSDT)
2. Concise Evaluation (expedited review program)
3. Singapore Reliance Program (expedited review program)

Only Full and Concise Evaluations will be impacted by this draft.

Full and Concise Documentation Exemptions

Full Evaluations will no longer require;

1. Letter of certification of the intended use/indication/packaging, Letter of certification of label and instruction for use from manufacturer or product owner
2. Safety declaration
3. Marketing history declaration
4. Proof of approval from authority in foreign countries

Concise Evaluation will no longer require;

1. Design verification and validation documents
2. Risk analysis
3. Destruction method

Medical devices and IVDs that qualify for a Concise evaluation will receive an expedited review. To see whether your medical device or IVD qualifies for a concise evaluation, visit our blog post about concise evaluations in Thailand here.

With regards to questions or comments,  feel free to contact Asia Actual today.