PMDA provides the following safety information regarding medical devices.
This webpage contains Dear Healthcare Professional Letters of Emergent Safety Communications (the Yellow Letter) and Rapid Safety Communications (the Blue Letter). The Yellow Letter provides emergent and important safety information about drugs and medical devices. The Blue Letter provides information that does not require emergent communications but should be promptly provided to alert healthcare professionals.
This section includes safety information (e.g. press release) announced by MHLW regarding medical devices.
This webpage contains the most recent Risk Communications from PMDA including early communications or ongoing safety review. The webpage intends to provide the public with easy access to important medical devices safety information.
This webpage contains the information announced by MHLW regarding medical devices on safety revisions of PRECAUTIONS in package inserts.
This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare. It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare professionals.
This webpage contains the information announced by MHLW regarding notification on self-check of medical devices.
This webpage contains PMDA Alert for Proper Use of Medical Devices.
Notifications issued from the Ministry of Health, Welfare and Labour (MHLW) related to safety measures for medical devices are listed here.