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Japan Medical Device Regulatory Strategy Report

In order to obtain marketing authorization to sell your medical device in Japan, you must first register your product(s) with the Pharmaceuticals and Medical Devices Agency (PMDA). In addition to PMDA registration, foreign manufacturers must also apply for Foreign Manufacturer Registration licenses, and renew them every 5 years.

All medical devices must receive authorization from the PMDA before they can be commercialized in the country, and most will require Quality Management System (QMS) certification. Your device's path to market in Japan depends on its classification, and whether similar products are already available in Japan. For more detailed information, see our PMDA approval process chart.

In Japan, foreign manufacturers have the option to submit their own device registrations via the Foreign Special Approval System. In this case, the manufacturer would appoint a local Designated Marketing Authorization Holder (DMAH) instead of a Marketing Authorization Holder (MAH).

Let Emergo assist you in evaluating the Japanese medical device regulatory framework as it applies to your device(s).

Emergo has a worldwide network of in-house consultants, as well as regulatory and industry contacts, that enable us to provide incisive, actionable analysis on various medical device markets, including Japan. Our Regulatory Pathway reporting service for Japan covers the following topics:

  • PMDA Regulatory Background
  • Foreign Manufacturer Accreditation Licensing
  • Product Assessment and Classification
  • In-Country Representation in Japan
  • Medical Device Registration Requirements
  • Labeling and Language Requirements
  • Costs and Timeframes
  • Japan Regulatory Roadmap

Please contact us for more information about our Regulatory Strategy Report for Japan.

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