Pmda - Pharmaceuticals and Medical Devices Agency
Menu
Close

Post-marketing Safety Measures

Notification on self-inspection (FY 2021)

Date Device name Notification on self-inspection (from MHLW)

July 13, 2021
HPB/GAD
Notification 0713 No.1
HPB/RMCPD
Notification 0713 No.1
HSB/IRDCD
Notification 0713 No.3
PSEHB/MDED
Notification 0713 No.1
PSEHB/PSD
Notification 0713 No.1
PSEHB/CND
Notification 0713 No.21

Reusable medical devices which can be contacted with brain, spine, dura mater, cerebral ganglion, spinal ganglion, retina or optic nerve

Prevention of Secondary Infection of Prion Diseases (Including Creutzfeldt-Jakob Disease) through Surgical Instruments [143 KB]

Report Form [45.4 KB]

Reference Material: Guideline on Prevention of Prion Disease Infections (2020) [63.5 KB]