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Safety Information Regarding Medical Devices

The PMDA provides the following safety information regarding medical devices.

Yellow Letter/Blue Letter

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.

Safety Information Announced by the MHLW

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

PMDA Risk Communications
(medical devices risk information of ongoing evaluation)

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.

Revisions of PRECAUTIONS

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

MHLW Pharmaceuticals and Medical Devices Safety Information (PMDSI)

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.

Notification on Self-inspection

This webpage contains information on notifications on the self-inspection of medical devices issued by the MHLW.

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 (medical devices)

Notifications issued by the MHLW related to safety measures for medical devices are listed here.

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