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