Ministry of Health requests inspection and review of medical equipment declaration procedures

The Ministry of Health has just sent a document to the Department of Health of provinces and cities across the country regarding the inspection and review of medical equipment declaration procedures.

According to the Ministry of Health , previously the Ministry of Health issued Official Dispatch No. 2098 to the Department of Health requesting to review and inspect the procedures for declaring medical equipment, including the procedures for declaring eligibility to manufacture medical equipment, the procedures for declaring eligibility to buy and sell medical equipment of types B, C, D and the procedures for declaring standards applicable to medical equipment of types A, B on the Online public service system on medical equipment management https://dmec.moh.gov.vn according to regulations in documents on medical equipment management.

However, the Ministry of Health has recently received some information related to medical equipment manufacturing and importing establishments lowering the risk level of medical equipment to classify the product as type A or B medical equipment and declaring the applicable standards for type A or B medical equipment not in accordance with regulations at the Department of Health.

In order to carry out the procedures for declaring medical equipment on the System https://dmec.moh.gov.vn under the jurisdiction of the Department of Health in accordance with regulations and promptly correct and handle violations (if any); the Ministry of Health requests the Department of Health to urgently issue a document requesting establishments producing, trading, importing and exporting medical equipment in the area to:

Event - Ministry of Health requests to check and review medical equipment declaration procedures — The Ministry of Health requires inspection and review of medical equipment declaration procedures.

Review the medical equipment declaration dossiers on the System https://dmec.moh.gov.vn in accordance with the provisions of Decree No. 36, Decree No. 98 of the Government on medical equipment management and related documents. In particular, note to review the results of medical equipment classification to ensure compliance with the regulations on medical equipment classification;

Check the legality and accuracy of the documents and papers submitted in the dossier and ensure that the documents and papers in the dossier are always valid during the implementation process, and be responsible for keeping the documents and papers in the submitted dossier according to the provisions of Decree No. 07 of the Government amending and supplementing a number of articles of Decree No. 98 of the Government on the management of medical equipment.

Urgently organize inspections, checks, and post-inspections of the implementation of procedures for declaring standards applicable to medical equipment of types A and B and withdraw the declaration number according to the provisions of Decree No. 36, Decree No. 98 on medical equipment management and Decree No. 07 of the Government amending and supplementing a number of articles of Decree No. 98 on medical equipment management, regulations on classification of medical equipment and related documents.

The Ministry of Health requests the Department of Health of provinces and cities to report to the Ministry of Health (through the Department of Infrastructure and Medical Equipment) the results of the review and inspection of cases where the procedures for declaring medical equipment at the Department of Health are not in accordance with regulations as requested in Official Dispatch No. 2098 of the Ministry of Health;

At the same time, report to the Ministry of Health to inform the Leaders and specialists at the Department of Health in charge of medical equipment declaration procedures (including the following information: Full name, phone number, email address) before January 15, 2024 .

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