The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA) has introduced a Positive List pathway for eligible Class 1 low-risk medical devices, equivalent to ASEAN Class A.
Qualifying products may use an auto-approval registration process, providing a more streamlined route to market.
Under this pathway, the e-submission system pre-populates key product information, including the generic name, GMDN code, classification rule, risk classification, and product category, helping to reduce administrative requirements for applicants.
Read the Thai FDA guidance here:
https://medical.fda.moph.go.th/press-release/class1-positivelist
Purpose of the Pathway
To streamline the registration of eligible low-risk medical devices through a Positive List and automatic approval process.
The pathway is available only to products that meet the specified eligibility criteria and are included in the Thai FDA Positive List within the e-submission system.
Eligibility Criteria
To qualify for the Positive List pathway, a medical device must:
- Be classified as Class 1, equivalent to ASEAN Class A.
- Be included in the Thai FDA Positive List available through the e-submission system.
- Be intended for professional use only, except patient transfer and patient support devices, which may also be used at home.
- Not be sterile or have a measuring function. Where both sterile and non-sterile versions exist, only the non-sterile version is eligible for this pathway.
- Meet the applicable grouping requirements.
For reusable surgical instruments, the device must not be connected to an active medical device and must meet the applicable grouping requirements.
Auto-Approval Process
For eligible products, the system pre-populates key regulatory information, such as:
- Generic name
- GMDN code
- Classification rule
- Risk classification
- Product category
This reduces the amount of information applicants need to enter manually and supports automatic approval where the applicable requirements and documentation are satisfied.
Examples of Products Included in the Positive List
Examples currently included in the Positive List include:
- Wheelchairs, stretchers, crutches, and walkers
- Orthoses, splints, and external support devices
- Reusable surgical instruments that are not connected to active medical devices
- Blood collection tubes and specimen collection containers
- Examination lamps and surgical headlights
Eligibility should still be confirmed through the Thai FDA e-submission system before using the Positive List pathway.
Implications to Clients
Manufacturers and importers should verify product eligibility before selecting the Positive List pathway.
Eligible Class 1 devices may benefit from a faster and more efficient registration process through automatic approval, provided that the product meets all applicable criteria and complete documentation is submitted.
Companies should pay particular attention to intended use, sterility, measuring functions, device grouping, and whether the product appears on the current Positive List.
Products found to be ineligible after approval may be subject to registration cancellation by Thai FDA. Accurate product classification and pathway selection are therefore important when preparing the submission.
Effective Date
Informational guidance only.
No new regulatory requirement or specific effective date was announced.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.