EMERGO SUMMARY OF KEY POINTS:

• Japanese QMS conformity assessment fees for Class II medical devices will be reduced by 30%.
• The fee reductions take effect in April 2017.

Japanese medical device market regulators plan to reduce conformity assessment fees for certain device quality management systems by 30% in April 2017.

According to the Pharmaceutical and Food Safety Bureau of Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA), the conformity assessment fee reduction applies to Class II device quality systems complying with MHLW Ministry Ordinance No. 169 requirements.

The fee reduction will take effect April 1, 2017.