Thailand: Criteria, Methods, And Conditions To Install Medical Devices Outside The Premises Specified In The Certificate

On April 25, 2024, the Ministry of Public Health (MOPH) announced the Criteria, Methods, and Conditions for Assembly to Install Medical Devices Outside the Place Specified in the Certificate of Establishment, License, Notification license, or Listing License, B.E. 2567 (2024).

The registrant, licensee, notifier, or the listing licensee who assembles and installs medical devices outside of the location specified in the certificate shall comply with the criteria below:

1. Prepare documentation that defines the acceptance criteria for the installation, testing, and verification of the medical device system.
2. Set up installation-specific qualifications, inspection methods, testing procedures, and verification methods for medical devices with special installation requirements. Implement methods for continuous testing and verifying installation compliance with the defined specifications.
3. Set up a method for inspecting the installed medical device and testing and verifying the system as specified.
4. Set up designation and inspection for devices for testing and maintenance of medical devices to make sure it is calibrated or verified periodically.
5. Set up the process of calibration and maintenance of the equipment used for testing.
6. Maintain testing, system verification, installation, calibration, and maintenance records.

The provided criteria above exclude the process of assembling components and devices to form a complete medical device ready for use as intended by the manufacturer or product owner.

According to this notification, the license holder shall collect documents and evidence of assembly for the installation of medical devices with the requirements below:

1. Form of documents : either hard copy or electronic file
2. Language : either Thai or English
3. Collect documents at the place specified in the certificate of establishment, license, notification license, or listing license, or the place where the medical device is assembled for installation.

If a medical device does not have an expiration date, it must be kept for at least 5 years from the date of installation. If it has an expiration date, it must be kept for at least 1 year from that date.

This notification shall come into force 1 (one) year after the date of its publication in the Government Gazette (Published in the Government Gazette, Volume 141, Special Issue 152 D, pages 9-10, dated 4 June 2024). Further information on this MOPH notification can be accessed here กองควบคุมเครื่องมือแพทย์ (moph.go.th) (in Thai).

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