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