Regulatory Affairs Update: Vietnam

Vietnam: Announcement Regarding the Update of Documents on the DMEC System

On August 16, 2024, the Department of Medical Infrastructure and Equipment issued an announcement to registration facilities regarding the update of documents on the DMEC website. The Department requires registration facilities to follow up the processing progress and update the documents on the system as per the following guidelines:

  • Instructions for updating documents related to changes in registration information

The registration facility must submit the following documents:

(1) A document requesting to change one of the following types of information: Name of the registration facility or Address of the registration facility or Legal representative of the registration facility.

(2) The supporting documents attached are: The business registration certificate of the registered establishment showing the above-mentioned change information.

  • Instructions for updating documents related to the validity of legal documents

The registration facility must submit the following documents:

(1) A written request to update documents related to the validity of legal documents, including information about the registration dossier number and clearly stating the content of the updated validity of which legal documents.

(2) The accompanying supporting documents are one of the following legal documents: ISO 13485 Quality Management Certificate, Letter of Authorization, Free Sale Certificate, Market Authorization issued by one of the reference countries.

Updated documents can be submitted on the online portal of MoH even while the application is being processed to facilitate the registration process.

For more details on the regulation, please refer to this link: 317_HTTB_DKKD.pdf (in Vietnamese).

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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