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Medical Device Japan Entry Support

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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

Our Strength by the Numbers

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.

Strengths and Experience
  • Regulatory approval
    and clearance
    More than200
  • Establishment of new
    reimbursement
    7
  • Number of
    products sold
    300or more
  • Experienced
    clinical fields
    16or more
  • History in the industry
    50years

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.

  • Market Entry Support and Market Research
    Market Entry Support and Market Research
    We 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
  • Regulatory and Reimbursement Strategy Support
    Regulatory and Reimbursement Strategy Support
    Our 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
  • Sales Expansion Support
    Sales Expansion Support
    We offer support for post-market sales, marketing assistance, and distributor matching after the product is launched.
    • Marketing strategies
    • Sales
    • Distributor matching
    • DMAH
  • Logistics and Customer Support
    Logistics and Customer Support
    We 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

  • アイコン
    We are not sure if there is a demand for the developed product.
    Proposal
    Market research and interviews with medical institutions
  • アイコン
    We want to obtain regulatory approval, but we don’t know where to start.
    Proposal
    MHLW & PMDA
    Consultation support
  • アイコン
    We would like support for everything until sales.
    Proposal
    Comprehensive support from market research to sales, everything

Flow

The following is the general process.
  • STEP01
    Initial Meeting
  • STEP02
    Signing of NDA
  • STEP03
    Initial Quotation and Proposal
  • STEP04
    Agreement and Contract Signing
  • STEP05
    Service Commencement

Service Inquiries

For questions or consultations about our services, please contact us through the inquiry form.

FAQ

Q
Can we request services limited to market research or regulatory consulting only?

Yes, we offer consulting services on a spot basis as well.

Q
How much do the services cost?

We provide quotations based on your specific needs. Please contact us for a consultation.

Q
Is it possible for us to ask for DMAH services?

Yes, we can accommodate that.

Inquiry form for
Japan MedicalDevice Entry Service

Thank you very much for your interest in our service. For any questions or inquiries regarding our services, please feel free to contact us here. After reviewing your inquiry, our representative will get back to you shortly
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