Regulatory Updates

The Secretary-General of the Food and Drug Administration hereby issues the draft announcement as follows: Section 1: This Announcement shall be effective from the day following its publication in the Government Gazette. Section 2: Guidelines for submitting applications for medical device advertising that requires academic document evaluation are as follows:

Following the authority conferred by Section 5(1) of the Medical Device Act B.E. 2551 (2008) and Section 41(7) as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), the Minister of Public Health hereby issues the following announcement: The registrant shall prepare signage to display the supervisor’s name

On May 20, 2024, the Ministry of Public Health of Thailand issued a notification governing medical devices that require Supervisors for Control of Production, Import, or Sale and the qualifications, number, and duties of such supervisors, B.E. 2567 (2024). Medical device operators must appoint at least one supervisor with qualifications

In a newsletter article last June 28, 2024, the Thailand Food and Drug Association (TFDA) shared news that they will be collaborating with agencies to discuss the draft of medical device laws to adjust the registration of diagnostic test kits and reagents for COVID-19 to be based on risk classification