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Post-marketing Safety Measures

Notifications Related to Safety Measures (in vitro diagnostics)

This webpage contains information on notifications issued by the Ministry of Health, Labour and Welfare (MHLW) related to safety measures for in vitro diagnostics.

Date Title
PMDA/CSO No.60
February 17, 2023
Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. 
English-translated notification [252 KB]
Original notification in Japanese [1,024 KB]
July 29, 2022
Administrative Notice
Consultation Associated With Revision, etc. of Package Inserts, etc. for In Vitro Diagnostics
English-translated administrative notice [68.3 KB]
Original administrative notice in Japanese [179 KB]