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 and duties for production, import, or sale to achieve efficiency and quality.
If the same establishment engages with multi-functions such as production, import, and sellers who require a sales license, it must appoint a supervisor as mandated by this announcement. It is permissible for the same individual to fulfill multiple roles, provided they meet all qualifications and duties stipulated herein.
Business operators can be appointed supervisors if they meet the qualifications to control medical device production, import, and sale.
If the supervisors no longer want to perform the role of controlling production, import, or sales, they must inform the licensor no more than 30 days from the date of termination.
Establishment registrant, licensee, or listing holder who holds the licenses before the effective date of this announcement shall inform the information, documents, and related evidence of the supervisor in writing to the licensor within a period of one year from the effective date of this announcement.
Any notification, contact, or other documentary evidence-issue shall proceed in accordance with the law on electronic administrative procedure.
Table for qualifications and duties:
| Type of supervisor | Qualifications | Duties |
|---|---|---|
| Production | a) Educational qualification one as follows: | a) Control and supervise production or sale under the quality management system of medical device production. |
| 1. Graduated with at least a bachelor's degree in science, pharmacy, medicine, engineering, medical technology, veterinary medicine, or other related scientific fields. | b) Control and supervise the production or sale of all production batches under the law, including verifying records of medical device production at the place. | |
| 2. A person who graduated with a bachelor's degree and has one year at least of experience in quality management systems for medical devices. | c) Control preparation of labels or medical device documentation. The statement must not be false, or exaggerated, be correct and complete before selling. (Medical Device Act B.E. 2551(2008) and amendment, section 44, 45) | |
| b) Being a resident of Thailand | d) Perform duties as assigned by the establishment registrant, licensee, notifier, or the listing holder. | |
| Import | a) Appoint at least one person who graduated with a bachelor's degree | a) Control import or sale under the quality system for importing or selling medical devices. |
| b) Being a resident of Thailand | b) Control preparation of labels or medical device documentation without showing any messages as false or exaggerated; be correct and complete before selling (Medical Device Act B.E. 2551(2008) and amendment, section 44, 45). | |
| c) Perform duties as assigned by the establishment registrant, licensee, notifier, or the listing holder. | ||
| Sale (only those who have the sales license) | a) Appoint at least one person who graduated with a bachelor's degree | a) Control sales under the medical device sales quality system. |
| b) Being a resident of Thailand | b) Control sales to be under the rules, process, and conditions according to sections 6 (3) (9) and (10) of the Medical Device Act B.E. 2551 (2008) |
This notification shall come into force on the day following its publication in the Royal Gazette [Published in Government Gazette, Vol. 141, Special Issue, Part169d, dated 20th June B.E. 2567 (2024)]. Further information of the notification can be accessed here กองควบคุมเครื่องมือแพทย์ (moph.go.th) (in Thai).
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