How To Determine The Expiry Date Of An IVD Reagent?

The shelf-life of an IVD reagent should be determined based on the real-time stability research. The real-time stability research should be completed before registration, including the testing of at least three batches stored under actual storage conditions until the end of the expiry date.

At the same time, considerations should be given to the adverse conditions of the product during storage, transportation, and use in corresponding stability studies. If the real-time stability study is still ongoing at the time of application, the expiry date can be determined based on the available data.

After all the stability studies are completed, the expiry date can be extended by applying for change of permission items.