Legal analysis:
1, with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel;
2, the enterprise should have with the products produced and the production scale of the production equipment, production, warehousing sites and environment (need to be dust-free aseptic workshop);
3, there is a production of medical devices for the quality of inspection of the Institutions 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 appropriate professional competence, and to master the national supervision and management of medical devices, laws, rules and regulations, and related product quality, technical regulations, the quality of the person in charge of the production shall not be responsible for the person in charge at the same time.
Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 14 of the first class of medical device products for the record and apply for registration of the second and third class of medical device products, the following information shall be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product testing reports;
(d) clinical evaluation information;
(e) the product quality management and supervision of medical devices. Clinical evaluation information;
(v) product specifications as well as labeling samples;
(vi) quality management system documents related to product development and production;
(vii) prove that the product is safe, effective and other information required.
The product inspection report shall meet the requirements of the State Council drug supervision and management department, can be the applicant for registration of medical devices, the filer of the self-inspection report, or commissioned by a qualified medical device inspection agency issued the inspection report.
Conforms to the provisions of Article 24 of the Regulations exempt from clinical evaluation of the situation, may be exempt from submitting clinical evaluation information.
Applicants for registration of medical devices, the filer shall ensure that the information submitted is legal, true, accurate, complete and traceable.