1, with a business premises and warehouses to match the scope of business, and specific requirements for its specific area;
2, with nationally recognized, and operating products related to the professional on duty;
3, with operating products related to the possession of secondary school education or above of the technicians;
4, with a quality management system compatible with the operation of medical devices;
5, with a medical device license for the operation of the medical device business license is required. p>
4, with the operation of medical devices and the appropriate quality management system. First, apply for a Class III medical device license need to submit the following materials:
1, product risk analysis information;
2, product technical requirements;
3, product inspection reports;
4, clinical evaluation information;
5, product specifications and labeling samples;
6, and product development, production Quality management system documents related to the development and production of the product;
7, to prove that the product is safe, effective and other information required.
2, medical device registrant, the filer shall fulfill the following obligations:
1, the establishment of quality management system appropriate to the product and maintain effective operation;
2, the development of post-marketing research and risk management plan and ensure the effective implementation;
3, according to the law, to carry out the monitoring of adverse events and reevaluation;
4, the establishment and implementation of product traceability and recall system;
6, with product development and production related quality management system;
7, other information required to prove that the product is safe, effective and efficient. Product traceability and recall system;
5, the State Council drug regulatory authorities stipulated other obligations.
In summary, engaged in medical device business activities, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices" Article 30 To engage in the production of medical devices, the following conditions shall be met:
(a) there is a production site, environmental conditions, production equipment and professional and technical personnel appropriate to the production of medical devices;
(b) there is a quality inspection of the production of medical devices, and the quality management system. The production of medical devices for quality inspection of the organization or full-time inspectors and inspection equipment;
(C) to ensure the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the product development, production process documentation requirements.