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Medical Device Consultation


Japan's unique manufacturing technology development is very active, but in the field of product development, the development speed is slower than in other countries. However, in product development, the speed of development is slower than in other countries, which often results in missed opportunities for market entry and overseas expansion.
The number of companies with strong intentions to expand their business overseas is increasing.
For doctors who need unapproved medical devices overseas We introduce information on overseas medical devices and act as an import agent for medical professionals (doctors, dentists, etc.) in Japan.

Medical devices approved by FDA, CE medical, KFDA, etc. are allowed to be imported by doctors under limited conditions. Importation by a physician is allowed under limited conditions.
Acting as an agent for pharmaceutical applications for overseas medical devices (individual physician import)
Latest information
Guidance
Required for import
Document preparation
Product delivery
After
Follow
We will provide you with the latest product information, prepare the necessary documents for import, and deliver the products to you. Follow-up services and troubleshooting We provide a one-stop service.
Overseas Expansion Support Flow
STEP
01
Hearing
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Determine which products are suitable for overseas expansion from all products handled
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Conduct competitive and regulatory research for each selected product.
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If we are already in contact with overseas markets, we will check and analyze their current status.
STEP
02
Planning
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Selecting an area for expansion
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Market research in the area to be expanded
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Legal, pharmaceutical and other regulatory research
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Confirmation of availability of human resources
STEP
03
Execution
- Search for companies and distributors that are interested in selling or co-developing products locally.
- Identify problems with current partners, if any, and investigate alternatives if necessary.
- Create a list of potential partners and rank them.
- Gather materials and set up meetings with prospective partners to discuss partnering.
- Negotiation of business terms and conditions for partnering
- Support for CE Mark acquisition and FDA application
- Support for various procedures for establishing a local subsidiary
STEP
04
Follow-up
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Build, maintain, and troubleshoot relationships with partners.
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Resolve problems or re-search for other candidates.
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Confirmation of the actual costs and benefits of overseas expansion
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Support for exhibiting at overseas exhibitions and trade fairs
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Organizational structure building
Hearing
STEP
01
Planning
02
STEP
Partnership Alliance
03
STEP
Follow-up
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Research candidate products (performance,
market acceptance, market growth potential)
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Develop the most strategic plan that fits your
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presence and budget
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Survey on companies expected to introduce products
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Bridging with potential customers
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Gathering materials and setting up meetings with potential partners
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Negotiation of business terms and conditions
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Hearing about desired products
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Confirmation of your company's presence and budget
Lepios Solution has experts with marketing experience from Boston Scientific, Medrad, Quintiles, Abbott, Tyco HealthCare, etc., who can help you develop an efficient and strategic market strategy.
Overseas Product Introduction Consulting Flow
04
STEP