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Thailand: Draft Guidance for the Production of Medical Devices that are Exempted under Section 27(8) B.E. 2008 in Thailand

The Ministry of Public Health (MOPH) in Thailand issued a draft guidance on criterions, procedures, and conditions for the production of medical devices that are exempt under Section 27(8) B.E. 2008.

The key points of the draft guidance are as follows:

1. Production of medical devices by a government agency for testing and calibrating medical devices requires approval and reporting.

  • Report shall be submitted within 90 days from the end of the testing / calibration, together with the evidence of disposal of the medical devices.

2. Production for donation to government agencies for disease prevention / treatment or the Thai Red Cross requires submission of certificate to show that the donation complies with the following conditions:

  • Donation does not provide commercial benefit to any particular person.
  • Donation is not a burden or an obligation to demand or repair or maintain.

3. Production during emergencies in response to a shortage caused by an emergency/disaster requires application, approval, and detailed reporting.

  • The production report shall be submitted within 90 days of the date of production. The report must specify the name of the medical device, the list, and the quantity of medical devices produced.
  • The sales report shall be submitted every 6 months. The report must specify the name of the medical device, the list, the quantity of medical devices sold, and the name of the buyer.

This draft guidance will come into effect on the date of its publication in the Government Gazette. Further information on the draft guidance can be found in the translated document that can be accessed here.

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