Medical Device and Digital Health

Japanese Medical device market is worth USD 38 billion according to MHLW (2020). It is the second largest market after the US. Japan MD market is expected to grow by 5.6% (2020-2025). The Japanese government is promoting digital health which will also drive growth especially for digital health such as SaMD and medical devices using Artificial Intelligence. 
Yakumed has been involved in the development and approval of medical device products and in the evaluation of SaMD and other digital health products for introduction into Japanese market.

We cover various aspects of the Japanese Pharmaceutical market

Market Research and Japan Entry

  • A detailed analysis based on interview with Japanese investigators/KOLs and desk top analysis
  • Regulatory analysis
  • Market access analysis
  • Product positioning
  • Commercial Sales Forecast and recommendations
  • Evaluation of different entry options to Japan market
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Comprehensive Regulatory Support

  • Regulatory and Clinical Development strategy
  • Alignment of Japan regulatory strategy with global strategy, Gap analysis
  • Evaluation of possible Regulatory pathways in Japan such as Sakigake
  • Preparation of the registration plans of Medical Devices including potentially required pre-Clinical Studies
  • Preparation for PMDA consultation
  • Preparation of Application file/STED
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Orphan Medical Device Designation

  • We provide full support to obtain orphan medical device designation in Japan
  • Robust strategy for Orphan designation including risks and mitigation measures
  • Lead Consultations with MHLW and interaction until designation is received
  • We also support process of obtaining funding from the Japanese government
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Representation in Japan for your company

  • For companies which do not have an affiliate in Japan, representation in Japan as In-country care taker. Yakumed will represent you in communication with PMDA, MHLW, potential partners and other stakeholders.
  • Support on all areas related to your clinical development, regulatory affairs, Orphan drug designation, business development and other areas.
  • Support in setting up a business affiliate in Japan as Marketing Authorization Holder (MAH)
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Partnering and Business Development

  • We have demonstrated experience in deal-making between Europe/US and Japanese companies.
  • Strategic leadership and operational support to identify and select best-fit potential partners or Designated Marketing Authorizing Holder (DMAH) in Japan.
  • We provide full support and facilitation throughout the whole process (from initial interactions, due-diligence and negotiations) until a deal is signed between both parties.
  • We increase the chances of success by helping you understanding the market dynamics, improve your value proposition of your asset for Japan. Our bilingual Japanese professionals will also help you avoid gaps of communication and cultural conflicts.
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Market Access

  • Explore various options for early access to Japan
  • Assessment of pricing and reimbursement for potential pricing early in development
  • Strategies to optimise National Health Insurance pricing and reimbursement
  • Preparation and submission of all required pricing documents to the Economic Division of MHLW
  • Negotiation with MHLW on pricing negotiations
  • Support on any other related or follow-up activities
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