I started planning my 2024 bone implant medical device in China, which belongs to the third class of medical device registered products, and also belongs to what everyone usually calls high-value consumables. The new version of the "Requirements for Medical Device Registration Application Materials and Approval Certificate File Format" puts forward new requirements for the registration and declaration of bone implantable medical device products.
Stability study of registered products for bone implantable medical devices
The new version of the "Requirements for Medical Device Registration Application Materials and Approval Certificate File Format" requires that the product stability study is divided into three parts on the basis of the original No. 43 document, including shelf life, use stability and transportation stability, adding that products with microbial limits should also consider the content of product shelf life, and also pointed out that not only sterile products need to consider the shelf life of products, but also non-sterilized products also need to pay attention.
The determination of the shelf life of bone implantable medical devices generally needs to consider two aspects: product and packaging, by examining the cycle of maintaining the stability of the product's own performance and the cycle of maintaining the sterility of the packaging, and selecting the shortest time period between the two, to determine the final shelf life of the product. If the bone implant medical device is made of inert material, only the period during which the packaging maintains the packaging performance and sterility performance can be considered as the shelf life of the product. The verification of the validity period of the packaging shelf can be carried out either by real-time aging test or accelerated aging test, and the performance of the packaging can be tested at a specific time point, such as tightness, packaging peel strength, etc., to determine whether it meets the expected requirements. If the constituent materials are greatly affected by time, environment and other factors, such as degradable polymer materials and degradable metal materials, it is necessary to verify the period of maintaining the stability of the product, and select a specific time point to test the performance of the product. For transport stability studies, if the transport process occurs before the product is stored, it is generally not necessary to consider the aging of the packaging.