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  • What information needs to be provided when applying for a change in the packaging specifications of in vitro diagnostic reagents?

What information needs to be provided when applying for a change in the packaging specifications of in vitro diagnostic reagents?

Friday, 23 April 2021 / Published in Medical Device, News, NMPA Registration in China

What information needs to be provided when applying for a change in the packaging specifications of in vitro diagnostic reagents?

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.

Tagged under: In vitro diagnostics, IVD reagents, packaging

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