Executive Documents, Legal grounds

Official Dispatch No. 317/HTTB-ĐKKD: Update of documents on the DMEC’s website for medical device management.

Official Dispatch No. 317/HTTB-ĐKKD, issued on August 16, 2024: Update of documents on DMEC’s webiste for medical device management.

According to the regulations, there are two cases where updates can be made to the registration dossier for medical device circulation, including:

  • Information about the registration establishment: such as the name of the establishment, address, and legal representative of the establishment.
  • Information on the validity of legal documents: including the ISO 13485 Certificate, the Letter of Authorization (LOA) from the medical device owner, and the Certificate of Free Sale (CFS).

Download here:

https://medgate.vn/wp-content/uploads/2024/08/CV_317_HTTB_DKKD.pdf

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