In accordance with the degree of risk of medical devices, medical devices business implementation of classification management. The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices for licensing management.
Enterprises engaged in the third class of medical devices business should also have to meet the requirements of quality management of medical devices business computer information management system to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.
A class of medical devices business license scope
A class of medical devices do not need a business license. Because a class of medical devices refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices. For example, scalpels, surgical scissors, manual beds, medical ice packs, cooling pads and so on. According to the "supervision and management of medical devices business approach" relevant provisions: in accordance with the degree of risk of medical devices, medical devices business implementation of classification management. The operation of Class I medical devices does not require licensing and filing, the operation of Class II medical devices to implement record management, the operation of Class III medical devices to implement licensing management. According to the "supervision and management of medical devices business approach" Article 7: engaged in the operation of medical devices, should have the following conditions:
(a) with the scope of business and business scale of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;
(b) with the scope of business and business scale (ii) with the scope of operation and scale of operation of the business, storage space;
(c) with the scope of operation and scale of operation of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(d) with the operation of medical devices with appropriate quality management system;
(e) with the operation of medical devices with appropriate professional guidance, Technical training and after-sales service capacity, or agreed by the relevant organizations to provide technical support. Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish in line with the quality of medical equipment business management requirements of the computer information management system.
How to apply for medical device business filing certificate
Enterprises can be based on the following matters, against the enterprise itself whether to meet, not meet to find ways to meet the requirements first:
1, with the production of medical devices compatible with the production site, environmental conditions, production equipment, as well as professional and technical personnel;
2, the enterprise should have with the production of the Emergency filing products and production scale of production equipment, production, warehousing space and environment (has a dust-free aseptic workshop);
3, the production of emergency filing of medical devices for quality inspection of the organization or full-time inspectors and inspection equipment;
4, the enterprise's production, quality and technical personnel should have the production of medical devices and the production of professional and technical personnel with appropriate professional Ability to master the national supervision and management of medical devices and related laws, rules and regulations, and related product quality, technology, the quality of the person in charge of production shall not be concurrently
Legal basis:
"Supervision and Management of Medical Devices," Article 4
According to the degree of risk of medical devices, medical devices business implementation of classification and management. The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices to implement the record management, the operation of Class III medical devices to implement licensing management.
Enterprises engaged in the third class of medical devices business should also have to meet the requirements of quality management of medical devices business computer information management system to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.