ORBIS Compliance

Japanese Ministry Updates Essential Principles for Class II Medical Devices

Published /Japan

Announcement from the Japanese Ministry of Health, Labour and Welfare

On September 20th of this year, the Japanese Ministry of Health, Labour and Welfare announced amendments to the Essential Principles for the following Class II medical devices:

  • Ophthalmic ultrasound imaging system
  • Ultrasound pachometer
  • Axial length measuring ultrasound system
  • Ophthalmic ultrasound imaging/axial length measuring system
  • Ultrasound corneal thickness/axial length measuring system
  • Powered keratome
  • Aqueous/flare cell analyzer

With these amendments in place, manufacturers may update the content under "compliance method" and/or "identification of specified documents" if they have scientifically supporting reasons. If manufacturers wish to change "Applicable" to "Not Applicable" or vice versa, they must consult with Registered Certified Bodies.

Reference

Link to Reference - https://www.std.pmda.go.jp/stdDB/Data/RefStd/Std_etc/R040920_0920-01_01.pdf

Japan Quick Facts

Regulatory AgencyMinistry of Internal Affairs and Communications (MIC)
Certification TypeVoluntary
License ValidityIndefinite
Application LanguageJapanese
Legal License HolderNot required
In-country Testing RequirementRequires testing

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