New Medical Device Regulations in Thailand

New Medical Device Regulations in Thailand

On February 15^th the Thai FDA published significant new guidance governing the classification, common submission dossier template requirements, fee schedule and transition plan for medical device registration. This action enhances the harmonization of Thailand’s Medical Device Act B.E. 2562 (2019) (Issue 2) and 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 Thai FDA will allow for some documentation, e.g. 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 Medical Device Directive. In the past, 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.

Risk Classification	Registration Pathway
Class 1 medical devices	ListingGovernment Fees: $105Review Timeline:    200 days(formerly applied to General Medical Devices with 10 day processing time)
Class 2 and 3 medical devices	NotificationGovernment Fees:  $1,080Review Timeline: 250 days(formerly applied to a handful of devices)
Class 4 medical devices	LicensingGovernment Fees:  $1,775Review Timeline: 300 days(formerly applied to a handful of devices)

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.

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.

Application groups can be:1. Single2. Family (similar design or variations)3. System (devices that work together)4. Set (2+ devices sold and imported together)5. IVD Test Kits (not including analyzers)6. IVD Cluster (same manufacturer and methodology)

Products within a Group must all have:1. One generic proprietary name2. One product name3. One common intended purpose

GUIDANCE DOCUMENTS

Guidance Document Name	Purpose
Ministerial Regulations, Medical Device Products required Listing Approval	Outlines classification criteria for a Class 1, Listing category.
Ministerial Regulations, Medical Device Products required Notification Approval	Outlines classification criteria for a Class 2 or 3, Notification category.
Ministerial Regulations, Medical Device Products required License Approval	Outlines classification criteria for a Class 4, Licensing category.
Ministerial Regulations, Medical Device Products required Listing Approval	Outlines documentation requirements for a Class 1 Listing Approval process
Ministerial Regulation: Notification Manufacture or Import Medical Device 2020	Outlines documentation requirements for a Class 2 or 3 Notification Approval process
Ministerial Regulations, Application for Permit and Issuance of License Manufacture or Import Medical Device, 2020	Outlines documentation requirements for a Class 4 Licensing Approval process

Source:

https://asiaactual.com/blog/thailand-implements-new-medical-device-regulations/