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.