On May 14, 2019, NMPA issued the "Guidelines for Lifetime Evaluation of Active Medical Devices" (hereinafter referred to as "Guidelines"), which will be implemented immediately.
This guideline applies specifically to active medical devices and is intended to guide medical device registration applicants with the submission of registration documents for the lifetime of active medical devices.
The definition of ‘product lifetime’ is thereby specified as the timespan from the manufacturing date of the final product to the expiration date. The expected lifetime refers to the expected period of time for the medical device registration applicant to ensure the safety and effectiveness of the respective product through risk management prior to registration. The lifespan of the declared product can be inferred through test verifications, comparisons to similar products, and reliable empirical data on the components. The applicant of the medical device registration shall then guarantee the safety and effectiveness of the product during the period of use. When the product's safety and effective performance is reduced to an unacceptable level during the life of the product, those responsible (the medical device registrant and / or the clinical institute) shall assess the risk and take appropriate measures.
The registrant shall evaluate the expiration date of the product according to the means provided in the guidelines. Each component (including the console and the accessory) shall be specifically evaluated and verified according to the respective clinical use situation. The lifetime evaluation report and verification report can further be submitted with reference to the template in the guidelines.
In addition, the information of repair and maintenance for the product shall be stated in the accompanying document of the product.