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Post-marketing Safety Measures

Notifications Related to Safety Measures (In-vitro Diagnostics)

Notifications issued from the Ministry of Health, Welfare and Labour (MHLW) and PMDA related to safety measures for in-vitro diagnostics are listed here.

Date Title Original in Japanese
(PDF or Link)
PMDA/CSO No.60
February 17, 2023
Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. PDF
July 29, 2022
PMDA/OIMS Notification No.0729001
PMDA/OPI Notification No.0729001
PMDA/OPII Notification No.0729001
PMDA/OMQVMD Notification No.0729001
Points to Consider, etc. for Consultation associated with Revision, etc. of Package Inserts, etc.
Note) Abolished on February 17, 2023.
PDF
July 29, 2022
Administrative Notice
Consultation associated with Revision, etc. of Package Inserts, etc. for in vitro Diagnostics PDF