Annex
Technical Review Guidelines for Service Life of Active Medical Device Registration
Effective Date: 5/8/2019
Active medical devices can achieve the functions of diagnosis, prevention, monitoring and treatment of diseases. In order to maintain the above functions in clinical use, the medical device registration applicant / registrant needs to determine the life of the product. During this period, in addition to ensuring that the product is used safely, it should also be used effectively. Similarly, within this period, it means that all risk control measures adopted by the product are still effective and the remaining known risks are still within acceptable limits. The purpose of this guideline is to guide researchers to analyze the product use period, guide medical device registration applicants / registrants to submit registration application materials for active medical device use periods, and guide reviewers to review relevant document
This guideline is a general requirement for the service life of active medical devices. Registration applicants should submit registration dossiers based on the characteristics of the to-be-registered product, and judge whether the specific content in the guideline is applicable. The reasons for non-applicable content should be detailed. Registration applicants can also use other alternative methods to meet regulatory requirements, but should provide detailed research and verification information.
