In China, the regulatory authorities for medical devices are the National Medical Products Administration and the drug regulatory authorities at the provincial and municipal levels. The National Medical Products Administration is abbreviated as NMPA
The National Medical Products Administration implements classified management of medical devices based on their risk levels.
The first category consists of medical devices with a low risk level, for which routine management can ensure their safety and effectiveness.
The second category consists of medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness.
The third category consists of medical devices with relatively high risks that require special measures for strict control and management to ensure their safety and effectiveness.
Different types of medical devices should apply for medical device registration certificates from the corresponding drug regulatory authorities:
For the filing of Class I medical devices within the territory, the filer shall submit the filing materials to the food and drug regulatory department of the city divided into districts.
The second category of medical devices within the territory shall be examined by the food and drug regulatory department of the province, autonomous region or municipality directly under the Central Government. After approval, a medical device registration certificate shall be issued.
Class III medical devices within the territory shall be examined by the National Medical Products Administration. After approval, a medical device registration certificate shall be issued.
For the filing of imported Class I medical devices, the filer shall submit the filing materials to the National Medical Products Administration.
The import of Class II and Class III medical devices shall be examined by the National Medical Products Administration. After approval, a medical device registration certificate shall be issued.
The registration and filing of medical devices in Hong Kong, Macao and Taiwan regions shall be handled in accordance with the procedures for imported medical devices.
Application process
01 Determine the product classification code
02 Conduct type inspection
03 Prepare the application documents
04 Submit the registration application and the physical education examination application
05 Filing and review
06 Review the application documents
07 Supplementary Information of the Enterprise
08 Review supplementary documents
09 Approval and Issuance of Certificate
10. Application for production license
Cycle
Class I (Product Filing) : 1 to 1.5 months
Class II (Product Registration) : 8 to 12 months
Class III (Product Registration) : 12 to 18 months
