Japan’s Ministry of Health, Labor and Welfare made an announcement on September 20th 2022, that the Essential Principles for the following Class II medical devices are amended.

  • 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

Manufacturers may change the content under “compliance method” and/or “Identification of specified documents”, if they have scientifically supporting reasons. If manufacturers would like to change “Applicable” to “Not Applicable” or “Not Applicable” to “Applicable,” consultation with RCB is required.