Domestic Medical Device Registration

Domestic medical device registration applicants and filers shall establish a quality management system related to product development and production, and maintain effective operation.
When applying for registration of domestic medical devices approved according to the special approval procedure for innovative medical devices, if the samples are entrusted to other enterprises for production, they should be entrusted to medical device production enterprises with corresponding production scope; When applying for registration of domestic medical devices that are not approved according to the special approval procedure for innovative medical devices, samples shall not be entrusted to other enterprises for production.

Personnel handling domestic medical device registration or filing affairs should have corresponding professional knowledge and be familiar with the laws, regulations, rules, and technical requirements for medical device registration or filing management.

The applicant or filer applying for registration or filing shall comply with the basic requirements for the safety and effectiveness of medical devices, ensure that the development process is standardized, and all data is true, complete, and traceable.

The materials for applying for registration or filing should be in Chinese. According to the translation of foreign language materials, the original text should also be provided. When citing unpublished literature and materials, proof of permission from the data owner should be provided.

The applicant and the filer are responsible for the authenticity of the information.

Imported medical devices that have been applied for registration or filed for record should have been approved for sale in the country (region) where the applicant or the registrant's registration or production address is located.

If the applicant or filer's country (region) of registration or production address does not manage the product as a medical device, the applicant or filer shall provide relevant proof documents, including proof documents that the country (region) of registration or production address allows the product to be launched for sale.

Overseas applicants or filers shall cooperate with overseas applicants or filers in carrying out relevant work through their representative offices established within China or designated corporate legal persons within China as agents.

In addition to handling domestic medical device registration or filing matters, agents should also bear the following responsibilities:
（1） Liaison with relevant food and drug regulatory authorities, overseas applicants or filers;
（2） To truthfully and accurately convey relevant regulations and technical requirements to the applicant or filer;
（3） Collect information on adverse events of medical devices after listing and provide feedback to overseas registrants or filers, while reporting to the corresponding food and drug regulatory authorities;
（4） Coordinate the product recall work after the medical device is launched, and report to the corresponding food and drug supervision and management department;
（5） Other joint and several liabilities related to product quality and after-sales service.

Domestic Medical Device Registration
In China, registration management is implemented for Class II and Class III medical devices.
For the filing of Class I medical devices within the territory, the registrant shall submit the filing materials to the food and drug supervision and administration department at the district level.
The second category of medical devices within the territory shall be reviewed and approved by the food and drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the central government, and a medical device registration certificate shall be issued after approval.
The third category of medical devices within the country shall be reviewed and approved by the State Food and Drug Administration, and a medical device registration certificate shall be issued after approval.
The filing of imported Class I medical devices requires the filing person to submit the filing materials to the State Food and Drug Administration.
The import of Class II and Class III medical devices shall be reviewed by the State Food and Drug Administration, and after approval, a medical device registration certificate shall be issued.
The registration and filing of medical devices in Hong Kong, Macau, and Taiwan shall be handled in accordance with imported medical devices.