Thailand Food and Drug Administration (TFDA) revised the medical device regulations in terms of the classification of the medical device, registration route, procedures, timelines, and fees. This new regulation has been forced since February 2021 for both medical devices and in-vitro diagnostic devices (IVDs).
This article would like to emphasize the transition phase for the Partial 2 submission which can be made within 3 years from 15 February 2021 and now is nearly the end of this transition phase, which will be on 15 February 2024. Back to the regulation, after 15 February 2021, all medical device registrations were required to comply with the new regulations and compile all the technical documents in the CSDT format for Full Submission and some exemption of the technical documents for Partial 2 Submission.
Partial 2 submission involved medical devices from Class II and III (Notified) and Class IV (Licensed) and the import licenses will be valid for 5 years. After the expiry of the import licenses, Full CSDT submission is required. Besides, the approval period for Partial 2 submission would be 4 months instead of 1 year.
The medical devices listed under Partial 2 submission are applied for all medical devices and IVDs products, except for products that are specified under the Ministerial Regulations for Notified or Licensed medical devices for manufacturing or import registration.
Partial 1 Submission is categorized for an import permit with validity less than 1 year from 15 February 2021, while Partial 2 Submission is categorized for an import permit with over 1 year from 15 February 2021.
TFDA aims to bring the regulations on par with other ASEAN countries and enhance the efficiency and safety of the medical devices market in Thailand.
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