Regarding Corrections to “Conformity Checklist for Designated Highly Controlled Medical Devices, etc. (Part 31)

Correction to the Conformity Checklist for Designated Highly Controlled Medical Devices

The Ministry of Health, Labor and Welfare has issued a correction to the Conformity Checklist for Designated Highly Controlled Medical Devices. This correction addresses additions and omissions of various medical devices and criteria. Key details include:

Error in Notification: The correction addresses an error in the previous notification and provides a table outlining the necessary amendments.

Distribution: The updated notice has been shared with relevant organizations, including the Pharmaceuticals and Medical Devices Agency and the Japan Federation of Medical Devices Associations.

Additions to the Checklist:

New single-use medical instruments have been added, including:

• Automatic suture devices
• Arthroscopic suture instruments
• Surgical staplers
• Wire and ligature passers
• Suture passers
• Staple removers
• Skin clips
• Scalp clips
• Surgical punches
• Aortic surgical punches
• Bone fusion instruments

These updates ensure that the checklist is aligned with the latest regulatory standards for highly controlled medical devices, ensuring better oversight and compliance.

Region: Japan

Source: https://savvy.praise-net.jp:8443/EWAP1_search/servlet/MainServlet