Regulations on the supervision and management of medical devices (published on January 4, 2000 by Decree No. 276 of the State Council of the People's Republic of China*** and the State Council on February 12, 2014, the State Council's 39th executive meeting was revised and adopted Revised according to the Decision of the State Council on Amending the Regulations on the Supervision and Management of Medical Devices on May 4, 2017 Revised by the State Council on December 21, 2020, the State Council's 119th (Revised and Adopted at the Standing Meeting) For example:
Article 13 The first class of medical devices to implement the management of product filing, the second and third class of medical devices to implement the management of product registration.
Medical device registrants, filers shall strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety, effectiveness and bear responsibility according to law.
Article XIV of the first class of medical device products for the record and apply for the second and third class of medical device product registration, the following information shall be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection reports;
(d) clinical evaluation information;
(e) Product instructions and labeling samples;
(F) and product development, production and quality management system documents;
(G) to 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.