As part of the transition of risk-based classification, the Thai FDA published an updated Announcements regarding Criteria, Methods, and Conditions for Medical Device Manufacturing, Importation, and Distribution Record or Report Preparation. Salient points are summarized below:
1) Withdrawal of previous Ministry of Public Health Announcement regarding Criteria, Methods, and Conditions for Medical Device Manufacturing, Importation and Distribution Record or Report Preparation.
2) Inclusion of the term Listing to refer to Class I medical device
3) An establishment must maintain the manufacturing, importation, or sales record of a medical device for not less than 5 years from the date of manufacture, importation, or sales. For medical devices with an expiration date, records must be kept for at least 1 year after the expiration but not more than 5 years from the date of importation or sales. For the complete details of the contents of the report, check out the regulation file.
4) Annual reports must be submitted to the Thai FDA by 31 march of the following year. A copy of the report must be maintained by the establishment.
5) In case of deactivation, termination, or non-renewal of the license, a detailed report must be submitted within 90 days from the date of revocation, non-renewal, or termination of the license. The establishment will then no longer be required to submit the documents by March of the following year but a copy must be kept by authorized personnel for evidence.
This decree is in force from 1st July 2021 onwards.