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

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

Thai FDA Updates Medical Device Application 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 TFDA medical device application 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.

TFDA Medical Device Application Fees

  • Risk Classification
  • Class 1
  • Class 2
  • Class 3
  • Class 4
  • Registration Type
  • Listing
  • Notification
  • Notification
  • License
  • Submission Fee
  • 500 Baht
    (US$ 17)
  • 1,000 Baht
    (US$ 33)
  • 1,000 Baht
    (US$ 33)
  • 1,000 Baht
    (US$105)
  • Specialist Review Fee (Novel Devices)
  • N/A
  • 38,000 Baht
    (US$ 1,267)
  • 38,000 Baht
    (US$ 1,267)
  • 53,000 Baht
    (US$ 1,767)
  • Approval Fee
  • 2,000 Baht
    (US$ 67)
  • 10,000 Baht
    (US$ 333)
  • 10,000 Baht
    (US$ 333)
  • 20,000 Baht
    (US$ 667)
  • Fee
    (not including Specialist Review)
  • 2,500 Baht
    (US$ 84)
  • 11,000 Baht
    (US$ 366)
  • 11,000 Baht
    (US$ 366)
  • 21,000 Baht
    (US$ 772)
  • Max Review Time
  • 200 days
  • 250 days
  • 250 days
  • 300 days

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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