Japan medical device QA/RA blog

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Japanese Regulators to Reduce Some QMS Assessment Fees 30% in 2017

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.

Japan QMS conformity assessment fee reduction in 2017 for Class II medical devicesJapanese 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.

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