THAILAND: New Regulation For Medical Device Registration from Thai FDA 2021

2021-03-22

The new announcement for the medical device regulation. Officially transits from policy-based classification to risk-based classification starting from Feb 15, 2021. So briefly introduction of medical device. Thai FDA categorized medical devices into 3 classes which are Licensed medical device, Notified medical device and Listing. So, the set of medical devices under each classification after implement risk-based classification which Thai FDA has aligned with ASEAN AMDD, will show in the table below:
Medical device classification in Thailand

Risk-Classification

Regulation in Thailand under
Policy-Classification

Non-IVD

IVD

Class 4
(High risk)

Licensed Medical Device

Class 3
(Moderate to high risk)

Notified Medical Device

Class 2
(Low to moderate risk)

Class 1
(low risk)

Listing

Besides, Thai FDA has announced the amended information in application forms for each classification according to above updated announcements but not significant amendment. Also, announced the exemption of Technical documents during transition phase for Notified medical device and Licensed medical devices. To prevent the medical insufficient as well as to conveniently apply submission as follow:

No.

Document lists

Notified MD

Licensed MD

Partial 1

Partial 2

Partial 1

Partial 2
1. 

Executive Summary

X

O

X

O
2. 

Essential Principles of Safety and Performance of Medical Device and method used to demonstrate conformity

X

X

X

X
3. 
  • Device description
  1. 1. Device description and features
  2. 2. Intended use
  3. 3. Indications
  4. 4. Instructions for use
  5. 5. Storage condition
  6. 6. Shelf life
  7. 7. Contraindications
  8. 8. Warning
  9. 9. Precautions
  10. 10. Potential adverse effects
  11. 11. Alternative therapy (If applicable)
  12. 12. Materials
  13. 13. Product specification
  14. 14. Other relevant specifications
  15. 15. Other descriptive information

O

O

O

O
4.

Summary of design verification and validation documents

X

X

X

X
5. 

Device labelling

O

O

O

O
6. 

Risk analysis

X

X

X

O
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

X

X

X

X
8. 

Ways of deterioration and the elimination of waste generated after use

X

X

X

X
9. 

Quality system certificate

X

O

X

O
10. 

Label or medical device documentation certificate and Intended for use or indication documentation certificate

X

X

X

X
11. 

Declaration of Conformity

O

O

O

O
12. 

Certificate or a letter indicating commercial marketing history

X

X

X

X
13. 

Certificate or a letter indicating safety

X

X

X

X
14. 

Certificate or a letter indicating the receipt of registration if there are registration in foreign countries.

X

X

X

X
15.

Letter of Authorization for Authorized representative

O

O

O

O
15. 

Declaration letter of grouping medical devices registration

If any

If any

If any

If any

Remarks:
Partial 1 Route: Applicable for Import Permit with less than 1 year validity from February 15, 2021 onward.
Partial 2 Route: Applicable for Import Permit with over 1 year validity from February 15, 2021 onward.
Obtained Import Permit with the incorrect Risk-classification status shall proceed Partial 1 or Partial 2 submission route within 3 years from 15 February, 2021 onward.

 

References:
Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Listing Medical Device Registration

Ministry of Public Health Announce Definitions of Medical Device that Manufacturer and Importer Must Proceed Medical Device To be Notified Registration (No. 2)  

Ministry of Public Health Announce Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration

Food and Drug Administration Announce regarding List of Licensed Medical Devices that Manufacturer / Importer are Exempted from Providing Certain Technical Documents

Food and Drug Administration Announce regarding List of Notified Medical Devices that Manufacturer / Importer are Exempted from Providing Certain Technical Documents

Food and Drug Administration Announce the Amended Application Forms for Licensed Medical Device Registration

Food and Drug Administration Announce the Amended Application Forms for Notified Medical Device Registration

THAILAND: THAI FDA ANNOUNCES DRAFT REGARDING MEDICAL DEVICE DEFINITIONS FOR RISK-BASED CLASSIFICATION – JULY,2020

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