SERVICES

Are you seeking to:

  • Research the Japanese market for your medical device?
  • Distribute your medical device in Japan?
  • Apply for medical device manufacture authorization?
  • Obtain Japanese marketing authorization for your medical device?
  • Understand Japanese reimbursement rules applicable to your medical device?
  • Obtain a Japanese legal opinion for your intellectual property rights?
  • Monitor performance or compliance of your existing Japanese distributor?
  • Supply parts to medical device Japanese manufacturers?
  • Partner with Japanese companies, universities or other Japanese stakeholders?
  • Source funding for your medical device from Japan?

☞We offer bilingual boutique one-stop medical device consulting services to fit your specific requirements.

 

Our services include

    • Japanese Agent Representation for Medical Device Manufacturers: D-MAH (click to learn more)
      Advisory services for the commercialization in Japan of medical devices manufactured by international companies, with the goal of enabling companies to enter Japan smoothly and economically, whilst maintaining control of their marketing authorizations and ensuring their Japanese distributors comply with business arrangements.
    • Japanese Market Research
      Our extensive reach within the Japanese medical industry guarantees an exceptional level of research.

 

 

Experience

Over 20 years of experience working with stakeholders and opinion leaders in the Japanese and global medical device sector.

 

Network

Our extensive network with Japan’s medical device community includes Japanese doctors, hospitals, clinics, researchers and universities, medical device manufacturers and distributors, regulatory agencies, life science financiers, and other key opinion leaders and stakeholders. Our global network extends our capabilities all the major geographic regions.

 

Information you may find helpful

Why should I export my device  to Japan?

  • Population of 127 million, 3rd largest global economy
  • Japan’s medical device market totals USD20 billion (USD24 billion, GBP15 billion, Euro18 billion) in 2012
  • 44.4% of medical devices were imported (JPY1,584 billion)
  • Medical device for treatment (pacemaker, implants, catheter etc.) had 52.7% of market share
  • Market size expected to reach $39 billion by 2015
  • Japan’s population is ageing at a faster rate than any other developed nation, spurring more demand for healthcare

Japanese Regulatory Framework

Accreditation

Additional Reference Points

 

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