The Minister of Public Health, upon the advice of the Medical Device Committee, established the criteria and methods for the transportation, storage, destruction, or disposal of medical devices under the Authority conferred by Section 5, Paragraph One, and Section 6 (16) of the Medical Device Act B.E. 2551 (2008).
Under this regulation, the registrants of establishments that manufacture or import medical devices that (1) contain mercury; (2) contain radioactive substances shall conduct a risk assessment that may arise from the transportation, storage, destruction, or disposal of medical devices by preparing standard documents for the management of such risks and comply with the following:
- Establish appropriate methods of transportation to ensure the safe delivery of medical devices from the point of origin to the destination without damage.
- Store medical devices properly in suitable packaging to prevent damage or changes that may occur during storage and distribution.
- If medical devices are found to be damaged, decommissioned, or need to be destroyed or decommissioned within the establishment, they should be stored separately in a designated area safely, with appropriate signage.
- In cases where other laws specify methods for transportation, storage, destruction, or decommissioning of medical devices, compliance with those laws is required.
- Provide a contact channel for providing information or advice to sellers, holders, or those who destroy or decommission medical devices, depending on the case.
Further information can be accessed here กองควบคุมเครื่องมือแพทย์ (moph.go.th) (in Thai). This announcement shall come into force 60 days after the date of its publication in the Royal Gazette [Published in the Royal Gazette on June 21, 2024, Volume 141, Special Part 171 D, Page 6].
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