The purpose of this WG is to discuss regulatory issues related to CoDx and a corresponding therapeutic product. The WG contributes to the development of relevant notifications and administrative notices issued by MHLW.
（Activity period:：From April, 2012）
Activities
Approved CDx in Japan
The activities conducted over the last five years.
Presentations
Quality Control of Software as a Medical Device for Genomic TestingThe 11th Symposium on the Industry-Government-Academia Collaborative Forefront Cancer Genome, Tokyo, Janan
December 2023