China's "Administrative Measures for the Registration and Filing of Medical Devices" stipulates that the imported second-class and third-class medical devices shall be reviewed by the national medical device management department, and the medical device registration certificate shall be issued after approval.
Legal basis: Article 8 of the Administrative Measures for Registration and Filing of Medical Devices: 1. Category I medical devices shall be subject to product filing management.
Category II and III medical devices shall be subject to product registration management.
For the filing of Class I medical devices in China, the filing person shall submit the filing materials to the municipal drug supervision and administration department with districts.
2. Class II medical devices in China shall be examined by the pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government, and the medical device registration certificate shall be issued after approval.
3. Class III medical devices in China shall be examined by the State Administration of Medical Devices, and a medical device registration certificate shall be issued after approval.
4. For the filing of Class I imported medical devices, the filer shall submit the filing materials to the State Administration of Medical Devices.
5. Category II and III imported medical devices shall be examined by the State Administration of Medical Devices, and medical device registration certificates shall be issued after approval.