On June 10, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products Administration) released the 2021 draft amendment of the guiding principles for the shelf-life of passive implantable medical device for registration and filing. The previous version of the guiding principles was issued in May 2017.
- Consider how to set shelf life from the initial stage of the product development, and how to confirm the shelf life of the product continuously before and after selling into the market.
- Validation tests of shelf life of medical devices usually include accelerated stability test, real-time stability test, etc.
- The accelerated stability test design is based on the assumption that the chemical reactions involved in material deterioration follow the Arrhenius reaction rate function. However, not all the chemical reaction rates of materials conform to this function with the change of temperature. Many accelerated aging tests used in medical devices of polymer materials have been estimated based on the zero-order, first-order and pseudo-first-order chemical reactions of this equation.
- Registered applicants are advised to set up multiple test observation time points (normally not less than 3) during the accelerated aging test. The zero-time performance data can be used as the reference index of the test items. The last observation point should be at least the same as the expected shelf life. Considering the complexity of changes in the real-world environment, it is recommended to set observation points longer than expected to declare shelf life.
- The shelf life verification test of medical devices should be carried out with the same final products as the conventional production, and the packaging without products can be used for the verification of suitable items (such as packing tightness). Validation of the appropriate batch of products may be considered if the differences between batches may affect the results of shelf life verification. After the applicant has fully assessed the product and packaging material characteristics, sterilization process and other influencing factors, one batch of products may be selected for testing when appropriate.
By Colleen Xu. Contact Cisema if you would like to learn more.