Yes, we offer consulting services on a spot basis as well.
About Service
Medical Device Japan Entry Support is a consulting service for
domestic and international companies engaged in medical device development.
We provide swift and efficient support for companies aiming to enter the Japanese market by ensuring compliance
with domestic regulations for medical devices. From market research to logistics,
we offer comprehensive assistance in the development and sale of medical devices.

Strengths and Experience
Drawing on half a century of experience in the medical device industry, our highly knowledgeable staff supports the development and sales of medical devices. Additionally, with our in-house team of professionals in clinical and regulatory affairs, quality assurance, and safety management, we are able to provide fast and reliable services.
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Regulatory approval
and clearanceMore than200 -
Establishment of new
reimbursement7 -
Number of
products sold300or more -
Experienced
clinical fields16or more -
History in the industry50years
Service
Flexible proposals tailored to your needs.
We offer comprehensive end-to-end support from initial market research to sales,
as well as spot support for each phase tailored to your needs.
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Market Entry Support and Market ResearchWe provide support for initial investigations towards sales, including related market research and setting up interviews with doctors.
- Market size research
- Product Evaluation
- Competitor analysis
- Doctor Interviews
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Regulatory and Reimbursement Strategy SupportOur specialized team supports the development of regulatory strategies and assists in the preparation of actual application documents. We also offer support for conducting clinical trials as needed.
- Developing strategies
- Consultation with PMDA
- Protocol design
- Preparation of applications
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Sales Expansion SupportWe offer support for post-market sales, marketing assistance, and distributor matching after the product is launched.
- Marketing strategies
- Sales
- Distributor matching
- DMAH
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Logistics and Customer SupportWe provide support for inventory management, logistics management, and quality control within Japan.
- Order processing
- Inventory management
- Logistics management
- Quality control

Service Inquiries
For questions or consultations about our services, please contact us through the inquiry form.
Case
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We are not sure if there is a demand for the developed product.ProposalMarket research and interviews with medical institutions
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We want to obtain regulatory approval, but we don’t know where to start.ProposalMHLW & PMDA
Consultation support -
We would like support for everything until sales.ProposalComprehensive support from market research to sales, everything
Flow
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STEP01Initial Meeting
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STEP02Signing of NDA
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STEP03Initial Quotation and Proposal
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STEP04Agreement and Contract Signing
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STEP05Service Commencement

Service Inquiries
For questions or consultations about our services, please contact us through the inquiry form.
FAQ
We provide quotations based on your specific needs. Please contact us for a consultation.
Yes, we can accommodate that.