The materials required for filing a class I medical device are: 1, a copy of the business license of the enterprise and a copy of the organization code certificate; 2. Legal ID card, production and quality management certificate; 3, the main production equipment and testing devices, product risk analysis data, safety risk analysis report; 4, product technical requirements, products in line with national industry standards list, product testing report, clinical evaluation data, product specifications and labels, manufacturing data, etc.
Legal objectivity:
Article 3 of the Measures for the Supervision and Administration of Medical Device Operation
China Food and Drug Administration is responsible for the supervision and management of medical device operation throughout the country. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative areas.
The food and drug supervision and administration department at the higher level is responsible for guiding and supervising the food and drug supervision and administration department at the lower level to carry out the supervision and administration of medical device operation.
Article 4
According to the risk degree of medical devices, medical devices are classified and managed.
There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.