Thailand Implements New Medical Device Regulations

On February 15^th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive. The guidance is effective immediately for all new registrations and means a substantially increased regulatory burden for the vast majority of medical devices.

Any applications under review will be processed according to the old rules. Any existing Import License will remain valid through its expiry date.

New Registrations

Applications submitted after February 15, 2021 will be subject to the new Rules. Class 2, 3, and 4 application will need to submit their applications in a format that closely aligns to the CSDT under either the Notified or Licensed route. For the first 3 years, the TFDA will allow for some documentation, like Risk Analysis and Proof of Foreign Country Approval, to be exempted from new applications but will then need to be provided during the review. For manufacturers with existing, fully completed CSDT files, it is recommended that the full document be submitted now though not all components are required.

Home country approval will no longer be required. Some documents like the Instructions for Use (IFU) and Labeling will need to be translated into Thai. Registrations will be valid for 5 years.

Products Already Registered

The Thai FDA has also provided transition guidance for products currently registered allowing for partial renewal applications to be submitted, generating an Import License good for 5 years. After this 5-year period, a full submission will be required. Products expiring in 2021 can be renewed with less documentation while registrations expiring in 2022 or beyond (under the old system) will require most of the CSDT documentation.

New Medical Device Classification System

The new regulations transition to a risk-based classification system based on ASEAN MDD guidance. Formerly most medical devices fell under the General Medical Device category and were subject to a simple listing process. Only handful of medical devices were subject to the more rigorous Notification and Licensing reviews. Now all Class 2, 3 and 4 device applications will require full technical data in Common Submission Dossier Template (CSDT) format with a grace period for some documents. Medical device Import License applications will need to be submitted via one of three routes (from low risk to high): Listings, Notifications, and Licenses. Certificates of Free Sale will no longer be required as part of the registration process.

Technical Documents in Common Submission Dossier Template (CSDT) Format

Notified and Licensed (Class 2, 3, and 4) Medical Device applications must adhere to the CSDT and will require the following documentation:

1. Executive Summary
   1. Device Description
   2. Intended use
   3. Indications
   4. Instruction for use
   5. Storage condition
   6. Shelf life
   7. Contradictions
   8. Warnings
   9. Precautions
   10. Potential adverse Effects
   11. Alternative Therapy
   12. Materials
   13. Other Relevant specifications
   14. Other descriptive Information
2. Device Labelling
3. Detailed Manufacturer Information
4. Essential Principles of Safety and Performance of Medical Device and Method Used to demonstrate conformity (Not Required for 3 years)
5. Summary of Design verification and validation documents
6. Risk Analysis (Not Required for 3 years)
7. Method of destruction
8. Quality Management Certification
9. Letter of Certification of the intended use/indication/ Package, Letter of certification of label and instruction for use from manufacturer or product owners
10. Declaration of Conformity
11. Letter of Confirmation for market history proof from manufacturer
12. Letter of Safety confirmation from manufacturer
13. Proof of approval from Medical Device Regulatory Authority in Foreign Countries (Not Required for 3 years)
14. Letter of Authorization as Distributor for Manufacturer
15. Grouping indication letter

Listed (Class 1) Product applications will require the following documents:

1. Import Licensed Establishment
2. Authorization letter
3. The documents that indicate names and information of medical device including Label, manufacturer and user manual
4. History of the registration in other countries.

New Fee Schedule for Medical Device Registration Processing

A summary of the changes has been included below.

New Grouping Guidance

The Thai FDA also issued new grouping guidance, allowing device applications to fall into 7 groups adhering to 3 rules.

To learn more about Grouping in Thailand, please go to our Grouping page that contains the full set of rules and examples for the various options.

Guidance Documents