1, licensing changes and registration changes in two matters. Medical device license license changes include quality management personnel, registered address, business scope, warehouse address (including the increase or decrease of warehouse) changes. The change of registration of medical device business license refers to the change of other matters other than the above. Detailed information can be found on the official website of the Medical Devices Service Group;
2, the enterprise should have with the production of products and production scale of the production equipment, production, warehousing space and environment (need to have a dust-free aseptic workshop);
3, there is the production of medical devices for quality inspection of the organization or a full-time inspectors and inspection equipment;
4, Enterprise production, quality and technical personnel should have with the production of medical devices appropriate professional competence, and master the national supervision and management of medical devices and related laws, rules and regulations of product quality, technology, the quality of the person in charge shall not be concurrently responsible for the production.
Legal basis
"Regulations for the Supervision and Administration of Medical Devices"
Article 23 For the newly developed medical devices not yet included in the classified directory, the applicant may apply for product registration in accordance with the provisions of these regulations relating to the registration of Class III medical devices directly, but also according to the classification rules to determine the product category and to the State Council drug supervision and management department to apply for category confirmation. After applying for product registration in accordance with the provisions of these regulations or product filing.
Directly apply for Class III medical device product registration, the State Council Drug Administration shall determine the category in accordance with the degree of risk, the registration of medical devices granted in a timely manner into the classification catalog. Application for category confirmation, the State Council Drug Administration shall accept the application from the date of 20 working days to determine the category of the medical device and inform the applicant. Article 24 The registration of medical device products, for the record, shall be clinically evaluated; but meet one of the following circumstances, can be exempted from clinical evaluation:
(a) the mechanism of work is clear, the design is stereotypical, the production process is mature, has been listed in the same variety of medical devices for many years of clinical application and no record of serious adverse events, do not change the routine use;
(b) other by non-clinical evaluation can prove that the medical device is safe and reliable. Clinical evaluation can prove that the medical device is safe and effective.
The State Council Drug Administration shall develop guidelines for the clinical evaluation of medical devices.