Thailand: Draft Guidance of Medical Devices Requiring a Production, Import, or Sale Controller
The Ministry of Public Health (MOPH) in Thailand issued a draft guidance specifying on three types of medical devices that require a production, import, or sale controller, such as:
- Viscous products for use in eye surgery
- Silicone breast implants for implantation in the body
- Hyaluronic acid injections for the correction of skin defects
The draft guidance specifies that the qualifications of a production, import, or sale controller include:
- Bachelor’s degree (scientific field for production/import controller).
- Minimum age 20.
- Thai residency.
- Knowledge of medical devices and quality systems.
- No bankruptcy or criminal convictions related to corruption or medical device offences.
- Not to be mentally incapable or incompetent or quasi-incompetent.
The draft guidance specifies that the duties of a production, import, or sale controller include:
- Production/Import Controller: ensure compliance with standards and regulations, prepare labels and instructions, maintain records, and submit reports.
- Sales Controller: ensure compliance with laws and regulations, prepare labels and instructions, maintain records, and submit reports. In production/import establishments that sell their own devices, the production/import controller can also serve as the sales controller.
The draft guidance will come into effect one year after the date of its publication in the Government Gazette. Further information on the draft guidance can be found in the translated document that can be accessed here.
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