The manufacturer should dynamically evaluate the service life of the product through risk analysis in the whole life cycle of the product. When there is no unacceptable risk within the service life of the product after listing, the expected service life determined before listing can be maintained; or the expected service life determined before listing can be extended after reassessment; when the safety and effective performance of the product after listing is reduced to the extent that the risk is unacceptable within the service life, the relevant responsible party (manufacturer and/or user) shall assess this risk and take corresponding measures.
The following aspects should be considered in the determination of the service life of active medical devices: key components such as high integrity components, usage frequency and intensity, transportation and storage, usage environment, cleaning, disinfection, sterilization, component maintenance and commercial factors, etc.
Sources: NMPA
