Ho Chi Minh City: "Circumventing the law" in declaring medical equipment, 70 records were revoked

According to the Ho Chi Minh City Department of Health , through the inspection of self-declaration procedures as medical devices on the Online Public Service System for Medical Device Management, the Department of Health discovered many cases of self-declaration that did not comply with regulations.

Accordingly, the Department issued 2 decisions to recall a total of 70 published standards for medical devices of type A and B. Specifically, Decision No. 2560/QD-SYT dated May 9, 2025 revoked 33 published numbers; Decision No. 2621/QD-SYT dated May 13, 2025 revoked 37 published numbers.

The reason for the recall is that the declared products do not meet the definition of medical devices or have an intended use that is not suitable for classification A or B (Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on the management of medical equipment and Official Dispatch No. 2098/BYT-TB-CT dated April 12, 2023 of the Ministry of Health on reviewing and checking the procedures for declaring medical equipment).

Ho Chi Minh City Department of Health will continue to strengthen medical equipment management in the coming time.

Through inspection, the Department of Health noted common errors in self-declared medical device dossiers. Specifically, these are products that do not meet the definition of medical devices such as: shampoo, shower gel, facial cleanser; traditional medicine, herbal medicine, chemical medicine, functional foods, etc.

The second is the misclassification of the risk level of medical devices. Instead of classifying high-risk products (such as IVD tests for HIV, HBV, HCV, etc.), they are classified as type A or B (to make it easier to publish), products containing pharmaceutical substances (which are actually drugs) are classified as medical devices, etc.

Third is the declaration of products whose intended use is not suitable for classification as a Class A or B medical device, particularly certain in vitro diagnostic (IVD) devices.

At the same time, the components of the self-declaration dossier are not in accordance with regulations such as: For imported medical equipment, there is a lack of a certificate of free circulation (CFS), for domestically produced medical equipment, there is a lack of a receipt for the self-declaration dossier of eligibility for production or information on the declaration number of eligibility for production, the self-declaration dossier of eligibility for resale lacks documents proving the storage warehouse, means of transporting medical equipment, etc.

In addition, incorrect profile information such as inappropriate ISO 13485 certificate, certificate of professional responsibility not in accordance with regulations; no label, instructions for use; purchase and sale records do not specifically state the list of medical equipment purchased and sold; use of abbreviations, symbols or general names instead of specific names of medical equipment...

Accordingly, the Department of Health recommends that individuals, units producing, trading and using medical equipment in Ho Chi Minh City need to master the regulations on medical equipment management, especially the regulations on classification and announcement of applicable standards.

At the same time, proactively review products and self-declared records of your unit to ensure compliance with regulations; strictly comply with the requirements of management agencies during inspection, examination, post-inspection, and cooperation to achieve the highest efficiency in medical equipment management.

In the coming time, the Ho Chi Minh City Department of Health will continue to strengthen the management of medical equipment and strictly handle cases of intentionally classifying medical equipment incorrectly for personal gain.

Source: https://baodautu.vn/tphcm-lach-luat-trong-cong-bo-thiet-bi-y-te-70-ho-so-bi-thu-hoi-d286447.html