On May 19, the Ho Chi Minh City Department of Health said that through the inspection of procedures for self-declaration of medical devices on the online public service system for medical device management, the unit discovered many cases of self-declaration that were not in accordance with regulations.
The Ho Chi Minh City Department of Health has issued 2 decisions to revoke a total of 70 publications of standards for the application of medical equipment of type A and B. The reason for the revocation is that the products announced are not in accordance with the definition of medical equipment or have a purpose of use that is not in accordance with classification A or B.
Through inspection, the Department of Health recorded many common errors in self-declaration records of medical equipment.
First, the product is not in accordance with the definition of medical equipment. Products that are not medical equipment according to regulations such as cosmetics (shams, shower gel, cleanser, etc.), traditional medicine, medicinal herbs, pharmaceuticals, and functional foods are declared as medical equipment.
Second, the classification of medical equipment is not in accordance with regulations. Accurately classifying the risk level of medical equipment, instead of having to classify high-risk products ( HIV testing IVD, HBV, HCV...) as classified as type A or B (to be announced more easily), products containing pharmaceutical substances (essentially drugs) are classified as medical equipment.
Third, the purpose of use is not suitable. Declare products with inappropriate uses to classify as type A or B medical equipment, especially some in vitro diagnostic equipment (IVD).
Fourth, the components of self-declaration documents are not in accordance with regulations such as for imported medical equipment, there is a lack of a Certificate of Free Cir circulation (CFS); domestically manufactured medical equipment lacks a Certificate of Receipt of self-declaration of Record Eligibility for Production or digital information to declare eligibility for production; The self-declaration dossier is eligible for purchase and reselling, lacking documents proving the warehouse, means of transporting medical equipment; The self-declaration dossier is eligible for production, lacking a Certificate meeting ISO 13485 quality management standards.
Fifth, the record information is incorrect. In particular, the ISO 13485 certificate is not suitable (the certificate of certification has not registered operating in Vietnam, the scope of inappropriate production ...); Literature of certificates of the person who is responsible for professionalism is not in accordance with the regulations; No labels, instructions for use; Buying and selling dossiers do not specify the list (name or group) of medical equipment to conduct purchase and sale; The circulation paper of the imported product does not show that the product has been allowed by the competent authority to circulate as medical equipment; ...
The Ho Chi Minh City Department of Health recommends that individuals and units producing, trading and using medical equipment in the area should pay special attention and strictly implement the regulations on medical equipment management, especially regulations on classification and promulgation of applicable standards.
At the same time, proactively review products and self-declared documents of their units to ensure compliance with regulations. Strictly comply with the requirements of management agencies during the inspection, examination, post-inspection, and cooperation process to ensure the highest efficiency of medical equipment management.
In the coming time, the Ho Chi Minh City Department of Health will continue to strengthen the management of medical equipment, strictly handling cases of intentional classification of medical equipment in violation of regulations for the benefit of the province.
