Links to major regulatory information of Companion Diagnostics(CDx).
Regulations and Notifications
Drug-Agnostic Companion Diagnostics
July 4, 2022 Administrative Notice
March 31, 2022 PFSB/ELD Notification No. 0331-1
March 31, 2022 Administrative Notice
Companion Diagnostics
December 26, 2013 Administrative Notice
July 1, 2013 PFSB/ELD Notification No. 0701-10
July 1, 2013 Administrative Notice
Genetic Testing Systems
April 28, 2016 PSEHB/MDRMPED Notification