Thai FDA issues new regulations on medical device classification and registration

Thai FDA issues new regulations on medical device classification and registration

The Thai FDA has issued new regulations for medical device classification and registration part of which came into effect on 15th February 2021 and the remainder comes into effect on 17th March 2021. The new regulations include changes in product classification for both IVD and non-IVD medical devices, types and stages of submission, groupings of medical devices, registration and importation processes as well as new timelines and fees.

New medical device risk classification categories
There are now 4 (four) risk classification categories as opposed to 3 (three) previously and they apply to both IVD and non-IVD products as follows:

Previous classificationNew classificationDate comes into force
 
GeneralClass 1 – ListingClass 1:
March 17, 2021
 
Notified
Class 2 – Notified
Class 3 – Notified
 
Classes 2, 3 and 4:
February 15, 2021
Licensed
Class 4 – Licensed
 

New medical device grouping rules
Previously, grouping was only allowed for Notified and Licensed medical devices, however in the new regulations all Classes 1, 2, 3 and 4 can benefit from grouping as one registration submission application as follows:

  • Single
  • System
  • Family
  • Set
  • IVD Test Kit
  • IVD Cluster

New submission rules
Previously all relevant documentation for registration applications had to be submitted in one single submission. However, under the new rules there are two stages of submission to be followed:

  • Pre-submission – in this first stage applicants will need to input information in the pre-submission system to confirm the risk classification and medical device grouping if applicable. The turnaround time is 15 days from submission and is free of charge.
  • E-submission – once the risk classification and grouping have been confirmed, applicants may proceed to e-submission. This stage involves the partial or full submission of all relevant documentation for product registration and is subject to new turnaround times and fees (see below). E-submission is already effective for Classes 2, 3 and 4 medical devices. All Class 1 medical devices will continue to use the current system up to and including 16th March 2021. The new system will become effective for Class 1 products on 17th March 2021.

New registration and importation processes

Depending upon the amount of time left in terms of validity of existing registration certificates there are different registration and importation processes to follow, with each having specific documentary requirements:

For Class 1 Listing Medical Devices:

  • Registered products with current approved certificates of less than 1 year of validity remaining as of the 15th February 2021 shall undertake Partial Submission of application for Medical Device Listing. Registered Products with Partial Submission can be imported to Thailand even while the process of approval from the Thai FDA is ongoing unless the application is rejected by Thai FDA. A Class 1 Listing Certificate is valid for 5 years. The full submission of documents is required during product renewal.
  • New products and registered products with current approved certificates of more than 1 year of validity remaining as of the 15th February 2021 are required to undergo Full Submission and require approval from the Thai FDA prior to importation of the products into Thailand.

For Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices:

  • Registered products with current approved certificates of less than 1 year of validity remaining as of the 15th February 2021 shall undertake Partial 1 Submission of application for Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices. Registered Products with Partial 1 Submission can be imported to Thailand even while the process of approval from the Thai FDA is ongoing unless the application is rejected by the Thai FDA. A Classes 2 and 3 Notified Certificate as well as a Class 4 License is valid for 5 years. The full submission of documents is required during product renewal.
  • Registered products with current approved certificates of more than 1 year of validity remaining as of the 15th February 2021 are required to undergo Full Submission. However, Partial 2 Submission is allowed for registrants who submitted their application within the following 3 years as from 15th February 2021 and require approval from the Thai FDA prior to importation of the products into Thailand.

New timelines and fees

Please find below the new fees and respective turnaround times for e-submissions the 4 different risk classifications.

Labelling – new regulations

New regulations for labelling of medical devices will come into effect on 31st October 2021 when it will become mandatory for labelling to be in Thai for all home use medical devices. However, for professional use medical devices, English labelling is acceptable.

Implications for medical device manufacturers

The registration process now has a longer lead-time and more documentation is required, as well as increased fees. To reduce this regulatory burden and cost, it will prove judicious to appoint a local authorized representative to handle registrations and act as a master distributor. The advantage being medical devices only need to be registered once; Thailand does allow for multiple registrants, however this will multiply the cost accordingly. Appointing an in-country representative gives you real flexibility in your distribution strategy to nominate as many distributors and sales partners as possible. This means you can adapt quickly to changes in the market by adding new distributors, increasing transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.

If you have any queries regarding the implications of the new regulations for either existing or new registrations in Thailand or want to know more about our local authorized representative services for Thailand, please contact us at contact@andamanmed.com

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