Class III medical device is a higher risk, need to take special measures to strictly control the management to ensure its effectiveness and safety of medical devices. Illegal production and operation of Class III medical device fine standard: the value of less than 10,000 yuan, a fine of 50,000 yuan more than 150,000 yuan; value of more than 10,000 yuan, a fine of 15 times the amount of more than 30 times the amount of the following fine; the circumstances are serious, and ordered to stop production and business, 10 years shall not accept the application for a permit for the proposed medical device.
Medical device classification standards:
1, according to the risk level: medical devices are divided into a class, class II and class III, the risk from low to high;
2, a class of medical devices: low risk, mainly by the manufacturer is responsible for ensuring the safety and effectiveness;
3, class II medical devices: medium risk, need to carry out rigorous control and management to ensure its Safety and effectiveness;
4, Class III medical devices: higher risk, need to be strictly reviewed and approved before use to ensure its safety and effectiveness;
5, classification based on: mainly based on the intended use of medical devices and the use of methods, as well as whether the human body in direct contact with the factors such as division.
In summary, the scope of business includes three categories of medical devices, and illegal production and operation of these devices will face severe fines and suspension of production and business punitive measures.
Legal basis:
"Supervision and Administration of Medical Devices Business"
Article 8
Engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal food and drug supervision and management department of the local district and submit the following information:
(a) a copy of the business license and organization code certificate;
(ii) legal representative, the person in charge of the enterprise, the quality of the person in charge of the identification, education or title certificate;
(iii) organization and departmental setup description;
(iv) the scope of business, the mode of operation description;
(v) the business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or lease agreement (with documents proving property rights) copies;
(F) business facilities, equipment directory;
(G) business quality management system, working procedures and other documents directory;
(H) computer information management system basic information and functional description;
(IX) proof of authorization of the operator;
(X) other supporting materials.