Technical Review Guideline for Change of Permission Items on IVD Products
On July 1, 2020, CMDE start to collect comments on the Technical Review Guideline for Change of Permission Items on IVD Products (Second Edition Draft). This guideline will apply to the changes of the main raw material supplier, test method, analytical performance, product technical requirements, positive judgment value or reference interval, product stability, packaging specifications, applicable instruments, production address, increase of applicable sample types, increase of applicable population, increase of clinical indications, or so on. Comments or opinions of all IVD manufacturers about this Guideline can be submitted by July 25, 2020, via email.
