Active Medical Device Lifetime Vs. Passive Medical Device Shelf-life

China NMPA requires medical device manufacturers to provide the product lifetime or shelf-life and related research material to support such claims.
For active medical devices, the lifetime can be determined by key component test, whole machine test, post-marketing experience data, or choose the most suitable one for your product.
For passive medical devices, the shelf life can be determined by real-time or accelerated aging tests. In the test, we should use three batches of products and pick three checkpoints. At each checkpoint, tests from the Product Technical Requirements (PTR) should be performed to examine the product’s performance.
Takeaway: Currently, it is unlikely to obtain NMPA approval without providing the lifetime or shelf-life research materials.