Since the costs to be collected from applicants in the medical device product licensing process are not appropriate for the current situation, it is expedient to determine the expenses in the review process to generate efficient management.
The recurrent fee will be determined into 2 accounts—(1) Assessment of academic documents and inspection the establishment and (2) Any consideration or examination other than Account 1.
Exemptions and Waivers
The FDA allows the applicants for medical device product approval to be exempted from all expenses if the device is for research and development purposes and related laws. Refer to item 5 in the list 2 provided in the table.
This Notification shall be effective from the day following the date of its publication in the Government Gazette – 9 AUG 2021. Former announcement shall be dismissed.
For the updated fee, see below:
Account 1: Assessment of academic documents and inspection the establishment
Account 2: Any consideration or assessment other than Account 1
The fees exclude the following:
(1) the cost of searching service, transporting documents and rental fee for collecting document from the Food and Drug Administration,
(2) copying of documents,
(3) traveling fee, and
(4) Excluding accommodation fee in case on in section outside country (Thailand).