The difference between the medical device record and license:
1, the record and license to adapt to the different categories of devices.
The operation of a class of medical devices, class II medical devices need to record the certificate, the operation of class III medical devices need to operate the production license.
2, the record and license of the management body is not necessarily the same.
The first class of medical devices in the territory of the municipal food and drug supervision and management departments to be filed.
Domestic Class III medical devices by the State Food and Drug Administration review, approval issued after the registration of medical devices.
The import of Class I medical devices by the State Food and Drug Administration for the record.
The import of Class II and Class III medical devices by the State Food and Drug Administration for review and approval issued after the medical device registration certificate.
3, the two based on different laws and regulations.
Record: "Medical Device Registration and Record Management Measures"
License: "Supervision and Administration of Medical Devices Regulations" and "Medical Device Business License Management Measures"
Expanded information:
The applicant for the registration of medical devices (hereinafter referred to as the applicant) refers to the application for the registration of medical devices, in the application approved by the holder of the registration card
The medical device filer (hereinafter referred to as the filer) refers to the medical device for the record, and in their own name to the market, the product is legally responsible for the product.
Application for registration or for the record of affairs should have the appropriate professional knowledge, familiar with the medical device registration or record management of laws, regulations, rules and technical requirements.
The filer should follow the basic requirements of safety and effectiveness of medical devices before applying for registration or filing, complete the development of medical devices, to ensure that the development process is real, standardized, all the data is real, complete and traceable. The development process should be consistent with the relevant requirements of the quality management system.