2, the product testing. For a class of medical device products can be out of the self-test report, they do not have the ability to test the products of class 1 need to commission a testing organization to test it. Two, three, class medical device products need to be commissioned with a nationally recognized testing organizations for testing, testing organizations to issue pre-evaluation and testing reports to the applicant. The production of registration test samples should be in line with the relevant requirements of the quality management system of medical devices, registration test qualified before clinical trials or apply for registration.
3, clinical trials. A class of medical device products do not need to conduct clinical trials, two or three types of medical devices if the product is not in the state issued a medical device exemption catalog or can not be compared with similar products to obtain information on clinical evaluation of data, it is necessary to conduct clinical trials.
4, the applicant should be in accordance with the relevant requirements to the food and drug supervision and management departments to submit the declaration information. Acceptance of the application for registration of food and drug supervision and management department shall, within three working days from the date of acceptance of the declaration of information forwarded to the technical review body, the technical review body should be completed within 60 working days of the technical review of the registration of Class II medical devices, within 90 working days to complete the registration of Class III medical devices, the technical review of the technical review of the work.
5, acceptance of the application for registration of food and drug supervision and management department shall make a decision within 20 working days after the end of the technical review. To meet the safety and efficacy requirements, registration is granted, from the date of approval decision within 10 working days to issue a medical device registration certificate, after approval of the product technical requirements in the form of an attachment to the applicant. Not registered, shall state the reasons in writing, and at the same time inform the applicant of the right to apply for review and apply for administrative reconsideration or administrative litigation.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article VII of the medical device products should be in line with the mandatory national standards for medical devices; there is no mandatory national standards should be in line with mandatory industry standards for medical devices.
Article VIII The state develops medical device industry planning and policy, medical device innovation into the development of key, innovative medical devices to be prioritized review and approval, to support the clinical promotion and use of innovative medical devices, and to promote the high-quality development of the medical device industry. The drug supervision and management department of the state council shall cooperate with the relevant departments of the state council, the implementation of the national medical device industry planning and guiding policies.
Article IX The State shall improve the medical device innovation system, support basic and applied research on medical devices, promote the promotion and application of new medical device technologies, and support scientific and technological projects, financing, credit, bidding and procurement, and medical insurance. Support enterprises to set up or joint research institutions, encourage enterprises and institutions of higher learning, research institutes, medical institutions and other cooperation to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the capability of independent innovation of medical devices.