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k.ikumi@medicolab.co.jp
Business Hours:9:30-19:30 JST

Medicolab Solutions

MEDICOLAB's Service Support for overseas MedTech companies in Japan
We provide a wide range of services for overseas MedTech companies related to regulatory approval, reimbursement, and commercialization activities in Japan. We help our clients achieve rapid and economical entry into the Japanese market while maintaining business leadership.

We provides comprehensive solutions for your company to success your business in Japan

Package

Opportunity Validation

・Patient Population Definition
・KOL Identification & Influencing
・Treatment Landscape Clarification
・Product Evaluation
・Pricing Assessment
・Opportunity Sizing

Clinical Development

・Clinical Trial Design
・KOL Engagement & Site Selection
・Clinical Operations & CRO Management
・GCP Compliance Assessments
・Post-Marketing Surveillance (PMS)
・Clinical Research Support

・Regulatory Strategy Formulation
・PMDA& MHLW Engagement
・KOL & Medical Society Engagement
・High Medical Needs & HBD Program Involvement
・Regulatory Documentation
・Q&A response for Certification/Approval

Reimbursement

・Reimbursement Strategy Formulation
・Medical Society Engagement
・Patient Group Engagement
・Treatment Guideline Influencing
・MHLW Engagement
・HTA & Health Economic Analysis
・Q&A response for Acceptance

Quality & Operations

・QMS Conformity Survey
・MAH/DMAH Services
・Importation & Market Release
・Labeling & Repackaging
・Warehousing & Logistics
・Safety management & Reporting of defects

Commercial Develpment

・Marketing & Business Strategy Development
・KOL & Rising KOL Engagement
・Advisory Board Establishment
・Congress Strategy & Implementation
・Clinical Education Program Development
・Clinical Research & Publication Support
・Distribution Partner Selection & Engagement

小見出し
ここをクリックして表示したいテキストを入力してください。テキストは「右寄せ」「中央寄せ」「左寄せ」といった整列方向、「太字」「斜体」「下線」「取り消し線」、「文字サイズ」「文字色」「文字の背景色」など細かく編集することができます。

Regulatory affairs consulting that enables foreign MedTech company to enter the Japanese market on their own initiative

 

Foreign MedTech companies are unable to take on the role of a manufacturing and sales business that has the necessary business license for selling medical devices in Japan, so they generally need to either 1) conclude an exclusive sales contract with a Japanese distributor that has the necessary business license, or 2) invest in the necessary personnel (establishment of a general manager, domestic quality operations manager, and safety manager) and infrastructure at a base in Japan.

By using our company, overseas manufacturers can achieve their strategies in a leading position while keeping initial investment for establishing a Japanese corporation to a minimum.

We also accept consultations from those who want to sell medical devices in Japan but do not have a manufacturing license and are looking for a company to outsource to, or those who are considering entering the medical device market but do not know how to start.

Please feel free to contact us.
In order to deploy your medical device in Japan, the following items must be fulfilled:

MAH/DMAH

*A corporation licensed as a "Manufacturing and Marketing Authorization Holder (MAH)" is responsible for the overall supervision of the quality, distribution, and post-sale safety management of medical devices to be distributed in the Japanese market as a license holder. Without the MAH, the medical device cannot be distributed in Japan.

*The "Appointed Foreign Marketing Authorization Holder (DMAH)" is a person who, like the manufacturing and marketing authorization holder, is responsible for comprehensively supervising the quality, distribution, and post-sale safety management of medical devices to be distributed in the Japanese market, but is only a domestic agent, not an approval holder.
Marketing authorization

・Establishment of three roles of "General Marketing Manager," "Domestic Quality Control Manager," and "Safety Control Manager" (Personnel who meet the qualification requirements are required for each position)
・Preparation and retention of documents and records (5 years and or 15 years retention) (QMS and GVP management)

Periodic audit after certification/approval

・QMS surveillance every year (renewal audit) 
・Periodic QMS conformity survey every 5 years

Cost of Maintaining Marketing Operation

・Keeping work and storage space (for product identification and inventory) for inspection
・Labor costs for the three functions and workers, as well as maintenance costs for the location

小見出し
ここをクリックして表示したいテキストを入力してください。テキストは「右寄せ」「中央寄せ」「左寄せ」といった整列方向、「太字」「斜体」「下線」「取り消し線」、「文字サイズ」「文字色」「文字の背景色」など細かく編集することができます。

Fee

Steps from application to service use
Flow

STEP 1
Introduction of your products and business from your company

Please give us an overview of your products and business.

STEP 2
Our surveillance for supporting your business

We will survey what we can do for you. If necessary, we will ask for more details in your products and business.

STEP 3
Quotation response from us

We will send you a quotation according to your request.

STEP 3
小見出し
ここをクリックして表示したいテキストを入力してください。テキストは「右寄せ」「中央寄せ」「左寄せ」といった整列方向、「太字」「斜体」「下線」「取り消し線」、「文字サイズ」「文字色」「文字の背景色」など細かく編集することができます。

Our regulatory affairs consulting service

・Handling skill Class II to Class III medical devices
・Management skill by experts with extensive knowledge and practical experience
・Smooth communication by our staff

We will respond to your concerns and troubles.
Reliable Support System

E-mail Support

We welcome your inquiries by e-mail, anytime, 24 hours a day, 7 days a week. Please contact us anytime.

Video Chat Support

We can also respond to your concerns or problems over the video chat.

小見出し
ここをクリックして表示したいテキストを入力してください。テキストは「右寄せ」「中央寄せ」「左寄せ」といった整列方向、「太字」「斜体」「下線」「取り消し線」、「文字サイズ」「文字色」「文字の背景色」など細かく編集することができます。

Contact us

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