Thailand Adds Qualified Personnel Requirements for Establishment Licensing

On June 20th, 2024, the Ministry of Public Health in Thailand issued a notification (Gazette Volume 141 Special Section 169 D, English Translation) that will effect medical device establishment licensing in regards to the appointment and qualifications of controllers for medical devices. The notification is to take immediate affect.

Manufacturing Controllers

All establishments, license holders, or notified entities must appoint at least one manufacturing controller with the following qualifications and duties:

Qualifications:

1. A bachelor’s degree or higher in Science, Pharmacy, Medicine, Engineering, Medical Technology, Veterinary Medicine, or other related scientific fields; or
2. A bachelor’s degree in any field with at least one year of experience in quality management systems for medical devices.
3. Must reside in Thailand.

The duties of Manufacturing Controllers include overseeing production or sales to ensure compliance with the manufacturing quality system, supervising production batches to meet legal standards and verifying control records, ensuring labels or Instructions for Use (IFU) are accurate and comply with Section 44 and Section 45 of the Medical Device Act B.E. 2551, and performing any additional duties assigned by the establishment.

Import Controllers

Qualifications and Duties:

1. Must hold a bachelor’s degree and reside in Thailand.
2. Control the import and sale process to ensure compliance with the quality system for importing and selling medical devices.
3. Ensure labels or IFU are accurate and comply with Section 44 and Section 45 of the Medical Device Act B.E. 2551.
4. Perform any additional duties assigned by the establishment.

Sales Controllers

Qualifications and Duties:

1. Must hold a bachelor’s degree and reside in Thailand.
2. Control the sales process to ensure compliance with the quality system for medical device sales.
3. Ensure compliance with criteria, methods, and conditions as outlined in Section 6 (3) (9) and (10) of the Medical Device Act B.E. 2551.

Additional Provisions

1. A single individual can serve as a manufacturing, import, or sales controller, provided they meet all required qualifications and duties.
2.  If a controller wishes to terminate their duties, the licensor must be notified within thirty days.
3. In case of temporary unavailability of a controller, a qualified substitute must be appointed to perform their duties.
4. Establishments registered before this notification’s effective date must comply within one year and submit necessary information and documents to the licensor.
5. Notifications, communications, and issuance of documents will follow electronic procedures, with alternatives provided if electronic methods are not possible.

Regulatory Requirements for Displaying Controller Information

In another notification (Notification in English), released on the same day, the Ministry of Public Health outlined new guidelines regarding the display of signage for those overseeing the manufacturing, import, or sale of medical devices. Under the authority of the Medical Devices Act, B.E. 2551 (2008) and its 2019 amendment, the Ministry mandates that businesses involved in these activities must prominently display a sign detailing the name and qualifications of the designated controller responsible for compliance. The sign must be

• crafted from permanent white material,
• should measure at least 20 by 50 centimeters,
• display controller’s full name and qualifications must in blue Thai letters and,
• no less than 3 centimeters in height, ensuring visibility and clarity.

This notification applies to all relevant establishments, including those registered before the notification’s effective date, which are required to comply within one year.

Asia Actual Thailand has drafted a flowchart for adding a controller to a medical device manufacturing/importing establishment license or sales license.

How to Register a Medical Device or IVD in Thailand

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