Japan medical device QA/RA blog

News and commentary on regulatory changes.

Japanese Regulators Raise Medical Device Registration Fees

EMERGO SUMMARY OF KEY POINTS:

  • The Japanese PMDA has increased marketing application review fees for nine medical device categories.
  • The new fees went into effect April 1, 2018.
  • PMDA application review fee increases range from eight to 15%.

Japan PMDA medical device application fee increases 2018Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has raised review fees for most device registration applications effective April 1, 2018.

The PMDA fee increases (link in Japanese) range from between eight and 15% across nine device categories, according to Emergo consultants in Tokyo. Reviews for Class II and III generic or improved devices without clinical data or approval standards, for example, increased by US $1,200 to about $15,525; Class IV new device review fees increased by $17,375 to $136, 080.

Other review categories whose fees have increased include:

  • Class II and III new devices
  • Class II and III improved devices with clinical data
  • Class II and III generic devices with approval standards
  • Class IV improved devices with clinical data
  • Class IV improved devices without clinical data or approval standards
  • Class IV generic devices without clinical data or approval standards
  • Class IV generic devices with approval standards

Related Japanese medical device regulatory information from Emergo:

  • Japan PMDA medical device registration consulting
  • Japan foreign medical device manufacturer registration support
  • Japanese medical device classification and JMDN code consulting
  • Video overview: Japan PMDA registration requirements
  • Whitepaper: Japan’s Pharmaceutical and Medical Devices Act (PMD Act)

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