Bryan Gilburg - China

“This announcement provides manufacturers with updated guidance on various costs associated with the newly implemented medical device regulations.”

Bryan Gilburg

Managing Director

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Thai FDA Updates Medical Devices Applications Fees

Published on: October 15th, 2021

On September 30, 2021 the Thai FDA published (reference Gazette Volume 138, Special Section 239N) a revised fee schedule covering medical and diagnostic device registration applications, license establishments, quality systems, and other review processes. In most cases the fees have been lowered from the levels established in February of this year. For example, Specialist Review fees for Class 3 and 4 applications have decreased by about 33%. This announcement provides manufacturers with updated guidance on various costs associated with the newly implemented medical device regulations.

Updated Specialist Review Fees

Specialist Reviews are optional for all Class 2, 3, and 4 applications the TFDA reserves the right to select any application for a Specialist Review. Most applications selected for this process have novel technology or indications for use in Thailand. Manufacturers trying to determine how likely one of their applications is to being selected for a Specialist Review fee should consider identifying predicate devices already on the market and submit a product comparison as part of the submitted documentation.

Specialist Review Fees for Initial Registration Applications

Medical Device Class Previous New
Baht USD Baht USD
Class 1 Listing 25,000 833
Class 2 Notification 38,000 1,267 38,000 1,267
Class 3 Notification 63,000 2,100 38,000 1,267
Class 4 Licensing 88,000 2,933 53,000 1,767
IVD Device Class Submission Fee Specialist Review Fee  (if required) Approval
Baht USD Baht USD Baht USD
Class 1 Listing 500 17 2,000 67
Class 2 Notification 1000 33 16,000 533 10,000 333
Class 3 Notification 1000 33 24,000 800 10,000 333
Class 4 Licensing 1000 33 30,000 1000 20,000 667
License Amendment

Specialist Review Fee (if required)

License Amendment

Specialist Review Fee (if required)

Non-IVD IVD Non-IVD IVD
Baht USD Baht USD Baht USD Baht USD
Class 1 19,000               633 17,000               567  –  –
Class 2 32,000            1,067 30,000           1,000 24,000    800 24,000           800
Class 3 44,000            1,467 40,000           1,333 24,000           800 24,000           800
Class 4 63,000            2,100 57,000           1,900 30,000        1,000 30,000        1,000

The Thai version can be found here.

Come Grow with Us

Contact Asia Actual if you’d like to learn how this new regulation update might affect your sales in Thailand.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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