The Thai Food and Drug Administration (Thai FDA), in collaboration with the Medical Device Authority (MDA) of Malaysia, has launched a pilot project to facilitate medical device registration in Thailand under the Regulatory Reliance framework, based on Good Reliance Practices.
Under this pilot initiative, the Thai FDA may rely on the assessment outcomes from Malaysia MDA specifically relating to quality, safety, and performance to streamline the registration process in Thailand.
Read the full announcement here: กองควบคุมเครื่องมือแพทย์
Purpose of the Pilot Project
To facilitate medical device registration in Thailand under the Regulatory Reliance framework, based on Good Reliance Practices.
To rely on the assessment outcomes from Malaysia MDA specifically relating to quality, safety, and performance to streamline the registration process in Thailand.
Eligibility Criteria
This pilot project applies only to medical devices that meet all of the following conditions:
- Applicable to Risk Class 2-4 medical devices classified (Class B–D) only.
- The medical device must have been approved by Malaysia MDA (excluding exempted product approval or Class A devices).
The product information submitted in Thailand must be identical to that approved in Malaysia, including:
- Trade name
- Model
- Product code
- Intended use and indications
- Labeling, packaging and instructions for use
- Submission Requirements
Applicants are required to submit:
- Full CSDT documentation, identical to that submitted to Malaysia MDA; and
- Proof of valid product registration in Malaysia.
Implications to Clients
Manufacturers and importers with medical devices already approved by Malaysia MDA may consider utilizing this pilot reliance pathway to facilitate registration in Thailand.
This initiative is expected to streamline the regulatory review, potentially reducing procedural complexities, review timelines, and associated costs.
Effective Date
01 February 2026 to 30 April 2026
For Inquiries
For inquiries or support regarding regulatory requirements for medical devices in Thailand, please contact sales@andamanmed.com.
