The National Medical Products Administration ("NMPA") has recently enacted and issued the Guiding Principles for Technical Reviews for the Registration of Service Life of Active Medical Devices (the "Guiding Principles").
The Guiding Principles are aimed at providing guidance for research fellows on the analysis of products' service life, for medical device registration applicants/registrants on the preparation and submission of necessary application materials to register the service life of active medical devices, and also for technical reviewers on the examination of relevant documents. Setting forth general requirements for service life of active medical devices, the Guiding Principles require that registration applicants shall submit application materials for the registration according to characteristics of the type of product to be registered, and identify whether specific contents of the Guiding Principles are applicable in their case. According to the Guiding Principles, if a particular safety attribute or a claimed performance, of a type of active medical device, may weaken as time goes on, its "service life" should be specified. Generally, there are two ways to determine a product's service life. For example, the medical device registration applicants/registrants may predetermine the service life based on assessment or experience, and then deploy one or multiple techniques to verify whether the pre-determined service life is reasonable or not.