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Medical Device Consultation 

医療機器コンサルテーション
医療機器の海外進出・日本市場への参入を成功に導く専門性の高いサービスの提供​

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. 

海外医療機器の薬事申請代行

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 

  • Determine which products are suitable for overseas expansion from all products handled

  • Conduct competitive and regulatory research for each selected product. 

  • If we are already in contact with overseas markets, we will check and analyze their current status.

STEP

02

Planning 

  • Selecting an area for expansion 

  • Market research in the area to be expanded 

  • Legal, pharmaceutical and other regulatory research 

  • 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 

  • Build, maintain, and troubleshoot relationships with partners. 

  • Resolve problems or re-search for other candidates. 

  • Confirmation of the actual costs and benefits of overseas expansion 

  • Support for exhibiting at overseas exhibitions and trade fairs 

  • Organizational structure building 

Hearing 

STEP

01

Planning 

02

STEP

Partnership Alliance 

03

STEP

Follow-up 

  • Research candidate products (performance,

 market acceptance, market growth potential)

  • Develop the most strategic plan that fits your

  • presence and budget 

  • Survey on companies expected to introduce products 

  • Bridging with potential customers

  • Gathering materials and setting up meetings with potential partners 

  • Negotiation of business terms and conditions

  • Hearing about desired products 

  • 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

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