THAILAND: New Medical Devices Registration Guidance for Licensed Medical Device, Notified Medical Device and Listing

2021-03-22

Thai FDA has announced the official medical device guidance regarding the technical documents requirements after promptly complete a transition from policy-based classification to risk-based classification of medical devices. These updated announcements are Technical documents for Licensed medical device registration, Notified medical device registration and document preparation for Listing registration as follow:

CSDT preparation for Licensed medical device and Notified medical device registration start implement from Feb 15, 2021

No.	Document lists
1.	Executive Summary
2.	Essential Principles of Safety and Performance of Medical Device and method used to demonstrate conformity
3.	Device description 1. Device description and features 2. Intended use 3. Indications 4. Instructions for use 5. Storage condition 6. Shelf life 7. Contraindications 8. Warning 9. Precautions 10. Potential adverse effects 11. Alternative therapy (If applicable) 12. Materials 13. Product specification 14. Other relevant specifications 15. Other descriptive information
4.	Summary of design verification and validation documents
5.	Device labelling
6.	Risk analysis
7.	Manufacturer information - Manufacturer name and address - Overview flow chart starting with Manufacture, Quality Control, Final product test, Packaging, Storage, Sterilization (if any), other related processes
8.	Ways of deterioration and the elimination of waste generated after use
9.	Quality system certificate
10.	Label or medical device documentation certificate and Intended for use or indication documentation certificate
11.	Declaration of Conformity
12.	Certificate or a letter indicating commercial marketing history
13.	Certificate or a letter indicating safety
14.	Certificate or a letter indicating the receipt of registration if there are registration in foreign countries.
15.	Letter of Authorization for Authorized representative
16.	Declaration letter of grouping medical devices registration

Note: Turnaround time for licensed medical device and notified medical device are 300 and 250 working days respectively

No.	Document lists
1.	Device description e.g. Device description and features
2.	Product specification
3.	Device labelling
4.	Certificate or a letter indicating commercial marketing history
5.	Sterilization test report if medical devices are sterile products
6.	Calibration test report if medical devices are measurement products (Metrological requirements)
7.	Declaration of Conformity
8.	Letter of Authorization for Authorized representative
9.	Declaration letter of grouping medical devices registration

Note: Turnaround time for listing is 200 working days
Since Thai FDA implement of updated announcements meanwhile government payable fee will be consequently updated and start implement on March 17, 2021.

Description	Fee (THB)
Licensed medical device manufacturing license	10,000
Licensed medical device import license	20,000
Notified medical device manufacturing license	5,000
Notified medical device import license	10,000
Listing medical device manufacturing license	1,000
Listing medical device import license	2,000
Application for Licensed medical device	1,000
Application for Notified medical device	1,000
Application for Listing medical device	500

Remark: Please kindly note that there is Medical Device Technical Document Evaluation Fee for Risk-classification based medical device registration in accordance with Attachment of Ministry of Public Health regarding Government Payable Fee for Medical Device Application and Evaluation 2017 as follow:
Evaluation request for manufacturing or importation of Licensed and Notified Medical Device that requires specialist to evaluate technical document. The fee varies in accordance with the risk classification rules of the medical device as follows:

Description	Price/Unit	Fee (THB)
Risk Classification 4	Per request	88,000
Risk Classification 3	Per request	63,000
Risk Classification 2	Per request	38,000
Risk Classification 1	Per request	25,000

References:
Ministerial Regulation Regarding Licensed medical devices for manufacturing or import registration

Ministerial Regulation Regarding Notified medical devices for manufacturing or import registration

Ministerial Regulation Regarding Listing medical devices for manufacturing or import registration

Ministerial Regulation Government Payable Fee for Medical Device Application 2020

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THAILAND: New Medical Devices Registration Guidance for Licensed Medical Device, Notified Medical Device and Listing

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