Apr 1, 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Japan’s PMDA has increased medical device registration fees as of Aprill 1, 2019.
  • Any Japanese market registration received after March 29, 2019 will be subject to the new fees.

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants.

The new fees have taken effect as of April 1, 2019 (link in Japanese). PMDA has issued three related documents to provide additional details regarding these increases:

  • Explanation of the Japanese Ministry of Health, Labour & Welfare’s order authorizing new PMDA registration fees, with related comparison tables;
  • Notice to Japanese regional authorities regarding implementation of revised PMDA fee structures;
  • Explanation of how PMDA will manage acceptance of registrations under previous versus new fee structures. (All links in Japanese.)

Deadlines for new PMDA fee structures

Japanese regulators have provided a schedule for how new medical device registration fee structures affect existing market applicants.

Applications received by PMDA by March 29, 2019 qualified for the agency’s previous fee structure; applications received on or after April 1 will be subject to the new fees, according to PMDA.

Learn more about Japanese medical device regulations and market opportunities at Emergo by UL:

  • Japan PMDA medical device registration and approval consulting
  • Foreign manufacturer registration in Japan
  • Medical Device Single Audit Program (MDSAP) training for manufacturers
  • Japan MHLW Ordinance 169 quality system compliance
  • Regulatory process chart: Japanese medical device registration
  • Whitepaper: Japan’s Pharmaceutical and Medical Devices Act