Thailand increases the requirements for qualified personnel for institutional licenses
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Thailand increases the requirements for qualified personnel for institutional licenses
Views: 200 Author: Site Editor Publish Time: 2024-07-31 Origin: Site
Thailand increases the requirements for qualified personnel for institutional licenses
On June 20, 2024, the Ministry of Public Health of Thailand issued a notice that would affect the appointment and qualification of medical device managers on the Establishment License of medical devices. The notice will take effect as soon as it is issued.
Manufacturing managers All institutions, license holders or entities must appoint at least one manufacturing manager with the following qualifications and responsibilities: Qualification requirements:
Bachelor's degree or higher in science, pharmacy, medicine, engineering, medical technology, veterinary medicine or other related disciplines; or
Bachelor's degree in any field, at least one year of experience in the quality management system of medical devices.
Must settle in Thailand.
The responsibilities of manufacturing managers include supervising production or sales to ensure compliance with the manufacturing quality system, supervising production batches to meet legal standards and verifying quality con
trol records, and ensuring that labels or instructions (IFU) are accurate and complying with the Medical Devices Act B.E. 2551 Chapters 44 and 45, and perform any other duties assigned by the enterprise.
Import managers Qualifications and responsibilities:
Must hold a bachelor's degree and settle in Thailand.
Control the import and sales process to ensure that the imported and sold medical devices comply with the quality system.
Ensure that the label or IFU is accurate and complies with the Medical Device Act B.E. 2551 Chapter 44 and Chapter 45.
Perform any other duties assigned by the enterprise.
Sales managers Qualifications and responsibilities
Must hold a bachelor's degree and settle in Thailand.
Control the sales process to ensure that the medical devices sold meet the quality system.
Ensure that the standards, methods and conditions outlined in Chapters 6 (3) (9) and (10) of the Medical Device Act B.E.2551 are met.
Supplementary conditions
A person can serve as a manufacturing, import or sales manager at the same time, provided that he must meet all the required qualifications and responsibilities.
If managers wish to terminate their duties, they must notify the licensor within 30 days.
If managers are temporarily unable to work, a qualified substitute must be appointed to perform their duties.
Enterprises that have been registered before the effective date of the notice must comply with the regulations within one year and submit the necessary information and documents to the licensor.
Notification, communication and document issuance will follow electronic procedures, and if the electronic method cannot be used, alternatives will be provided.
Regulatory requirements for displaying manager information In another notice issued on the same day, the Ministry of Public Health outlined new guidelines for personnel who supervise the manufacture, import or sale of medical devices to display logos. According to the Medical Device Act B.E. 2551 (2008) and the authorization of its 2019 amendment, the Ministry of Health stipulates that enterprises participating in these activities must display a signboard in a prominent position detailing the name and qualifications of the designated managers responsible for compliance. This sign must be:
Made of permanent white material;
Size requirements: the width is not less than 20cm, and the length is not less than 50cm;
The name and qualifications of the manager must be displayed in blue Thai letters;
And the font height is not less than 3 cm to ensure visibility and clarity.
The notice applies to all relevant enterprises, including those that have been registered before the effective date of the notice, which must comply with the regulations within one year.
How to register medical devices or IVD in Thailand
Do you want to register medical devices in Thailand?
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