Technical Review and IFU Updating Guidelines of Tumor CDx Based on Similar Therapeutic Drugs
On July 7, 2020, CMDE announced its preparation of Technical Review and IFU (instructions for use) Updating Guidelines of Tumor CDx Based on Similar Therapeutic Drugs (Draft).
These guidelines are drafted based on the 2020 Annual Medical Device Registration Technical Guidelines Revision Plan made by NMPA. Here, the Similar Therapeutic Drugs refer to at least two oncology therapeutic drugs that have obtained NMPA marketing approval for the same applicable population and the same bio-markers. All kinds of opinions are welcome to be filled in the information collection form and submit it to CMDE before August 3, 2020, via email.
