Regulatory affairs update Vietnam

Vietnam: Inspection And Review Of The Declaration Of The Applicable Standard Procedure In Vietnam

On 30 December 2023, the Vietnam Ministry of Health (MoH) issued Dispatch 8329/BYT-HTTB to the Local Health Department, requesting for the review on the implementation of the declaration of applicable standards within the area. This is due to the MoH receiving information that manufacturers or importers of medical devices have reduced the classification risk of the medical devices to Class A or Class B and submitted the declaration of the applicable standards dossier for the medical devices class A and class B wrongly.

As per the issued dispatch, the MoH urgently requests the Local Health Department to carry out the following actions:

1. Request trading, manufacturing, importing, and exporting establishments to carry out the following:

  • To review the applications that have been declared on the DMEC website, especially the classification results.
  • To verify the legality, accuracy, and validity of the submitted documents. Establishments shall ensure the documents are valid and is responsible to store the documents according to Degree 07/2023/NĐ-CP issued on 03 March 2023, amending and supplementing some articles of Decree 98/2021/NĐ-CP issued on 08 November 2021 of the Government on Medical Device Management.

2. Urgently organize inspections, verify, and post-audit on the declaration of applicable standards, and implement the revocation of the publication number in case of any violations as per regulations.

3. Report to the MoH on the results of the inspection for the cases of non-compliance and provide information of the Local Health Department expert who oversees evaluating the dossier of applicable standards for the medical devices.

Further information of the issued dispatch can be accessed here (in Vietnamese).

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