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Thailand: Amendment on The Format of The Establishment Registration Certificate for Medical Device Manufacturers and Importers

The Thailand Food and Drug Administration (FDA) announced an amendment to the format of establishment registration certificate for medical device manufacturers and importers. This announcement was in line with the newly issued regulations dated 30 August 2023, as follows:

  1. Ministerial Regulation Establishing the Criteria, Procedures, and Conditions for the Registration of Medical Device Manufacturing B.E. 2552 (4th Edition) B.E. 2566; and
  2. Ministerial Regulation Establishing the Criteria, Procedures, and Conditions for the Registration of Medical Device Importers B.E. 2552 (4th Edition) B.E. 2566.

The above-mentioned regulations became effective as per 01 September 2023.

The highlights of the announcement are as follows:

  1. The establishment registration certificate for medical device manufacturers shall follow the format in Form B.S.P.1 which can be accessed in this link. English version of the establishment registration certificate format can be accessed here.
  2. The establishment registration certificate for medical device importers shall follow the format in Form B.S.N.1 which can be accessed in this link. English version of the establishment registration certificate format can be accessed here.
  3. The establishment registration certificate for medical device manufacturers and importers that was issued prior to the publication of this Announcement shall remain valid and effective until their expiration or revocation, whichever comes first.

Comparison of the old version and new version of the establishment registration certificate can be accessed here.

Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.

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