Safety Information regarding Medical Devices

PMDA provides the following safety information regarding medical devices.

The Yellow Letter / Blue Letter

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.
 

Safety Information announced by MHLW

This section includes safety information (e.g. press release) announced by MHLW regarding medical devices.

PMDA Risk Communications
(Medical devices Risk Information of ongoing evaluation)

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.

Revisions of PRECAUTIONS

This webpage contains the information announced by MHLW regarding medical devices on safety revisions of PRECAUTIONS in package inserts.

MHLW Pharmaceuticals and Medical Devices Safety Information (PMDSI)

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.

Notification on self-check

This webpage contains the information announced by MHLW regarding notification on self-check of medical devices.

PMDA Alert for Proper Use of Medical Devices

This webpage contains PMDA Alert for Proper Use of Medical Devices.

PMDA Alert for Proper Use of Medical Devices (for patients)

This webpage contains PMDA Alert for Proper Use of Medical Devices (for patients).

Notifications Related to Safety Measures

Notifications issued from the Ministry of Health, Welfare and Labour (MHLW) related to safety measures for medical devices are listed here.