1, three types of medical equipment business license for the following:
(1) the applicant submits the application information to the relevant departments;
(2) the relevant departments to accept the applicant's application;
(3) to the actual site for investigation and review of products;
(4) granting the issue of the three medical equipment license;
(4) Granting of Class III Medical Device License.
2, the legal basis: "Supervision and Administration of Medical Devices Regulations" Article XIV
The first class of medical device products for the record and apply for registration of the second class, the third class of medical device products, the following information should be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection report;
(d) product inspection report;
(e) product safety and health, and the product safety and environmental protection.
(d) clinical evaluation information;
(e) product specifications as well as labeling samples;
(f) quality management system documents related to the development and production of the product;
(g) 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.
Two, three types of medical devices license registration what materials are needed
Three types of medical devices license registration required materials are as follows:
1, business name and scope of business, the registered capital and shareholders' capital contribution ratio, shareholders and other proof of identity;
2, medical device product registration certificates, suppliers' business licenses, permits and letters of authorization;
3, quality management documents, etc.
4, two or more medical or related professional certificates, identification and resume;
5, meet the requirements of the medical device business office space and warehouse certificates;
6, articles of incorporation, shareholders' resolutions, etc.;
7, the financial personnel identity card and induction certificate;
8, Other related materials.