HCMC: Detecting shower gel and functional foods "labeled" as medical devices

On the afternoon of May 19, the Ho Chi Minh City Department of Health announced that it had revoked dozens of medical equipment standards announcements that were not in accordance with regulations.

Accordingly, through the inspection of self-declaration procedures as medical equipment on the Online Public Service System on Medical Equipment Management (https://imda.moh.gov.vn/), the Department of Health discovered many cases of self-declaration that did not comply with regulations.

Therefore, the authorities have issued 2 decisions, withdrawing a total of 70 published standards for medical equipment of types A and B.

The reason for the recall is that the products are declared to be inconsistent with the definition of medical devices, or have an intended use that is not suitable for classification A or B.

Through inspection, the Department of Health noted a number of common errors in self-declared medical equipment records.

Firstly, the product does not meet the definition of medical equipment. Specifically, there are places that declare products such as cosmetics (shampoo, shower gel, facial cleanser...), traditional medicine, herbal medicine, chemical medicine, and functional foods as medical equipment.

Second, the classification of medical equipment is not in accordance with regulations: Some medical equipment, instead of being classified as high-risk products (such as IVD testing for HIV, HBV, HCV...), are classified as type A or B (to make it easier to publish), while products containing pharmaceutical ingredients (which are actually drugs) are classified as medical equipment.

Third, inappropriate use: Announce products with inappropriate use to be classified as medical devices of type A or B, especially some in vitro diagnostic medical devices (including reagents, calibrators, control materials...).

Fourth, the self-declared profile is not in accordance with regulations.

Fifth, the profile information is incorrect.

Medical equipment manufactured at Ho Chi Minh City High-Tech Park (Photo: WL).

The Ho Chi Minh City Department of Health recommends that individuals, units producing, trading and using medical equipment in the area pay special attention and strictly implement many contents.

Specifically, it is necessary to master the regulations on medical equipment management, especially the regulations on classification and announcement of applicable standards; Proactively review the products and self-declared records of your unit to ensure compliance with regulations;

Strictly comply with the requirements of the management agency during the inspection, examination, post-inspection process, and cooperate 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://dantri.com.vn/suc-khoe/tphcm-phat-hien-sua-tam-thuc-pham-chuc-nang-bi-gan-mac-thiet-bi-y-te-20250519151253425.htm