According to the announcement published by the CMDE (Centre for Medical Device Evaluation) of the National Medical Products Administration (NMPA) on April 12, 2021, all relevant potential risks should be identified when the packaging specifications of IVD reagents are being changed. In addition, the risk factors should be analyzed and validated.
Case Study I
If there are differences in the form of the reaction (e.g. drug assays) and the size of the reaction film strip (e.g. PCR amplification and hybridisation products), the assessment of the analytical performance should be submitted.
Case Study II
If significant changes in packaging specifications and containers have led to risks such as evaporation and loss, it is necessary to study and investigate whether the shelf life of the product, the stability of use, and the frequency of calibration is no longer the same.
By Jacky Li. Contact Cisema if you would like to learn more.