Regulatory Affairs Update Thailand

Thailand: Draft Guidance on the Temporary Storage of Medical Devices Outside Its Specified Location in the Certificate or License

The Ministry of Public Health (MOPH) of Thailand issued a draft guidance on the Temporary Storage of Medical Devices Outside the Location Specified in the Establishment Registration Certificate, Licenses, Notification Licenses, and Listing Certificates. The key points of the draft guidance are as follows:

1. Storage of medical devices outside its specified location as mentioned in the establishment registration certificate, license, notification licenses, and listing certificates could be permitted by submitting an application, stating:

  • the reason for the need;
  • period of temporary storage;
  • map location, floor map of storage, photographs of the storage area, lease agreements or other documents to show permission of usage as temporary storage.

2. The period of temporary storage shall not exceed 30 days. In this period as well, the establishment registration certificate must still be within its validity period.

This draft guidance shall come into effect after 180 days from the date of publication in the Royal Gazette. Further information on the draft guidance can be found in the translated document that can be accessed here.

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