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k.ikumi@medicolab.co.jp
Business Hours：9:30-19:30 JST
日本語
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Medicolab Solutions

MEDICOLAB's "Virtual Subsidiary" 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.
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We provides comprehensive solutions for your company to success your business in Japan

  • MEDICOLAB provides a unique platform for international MedTech companies, under the manufacturer's own management without an investment required for their own organization.

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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 Development

・Regulatory Strategy Formulation
・PMDA& MHLW Engagement
・KOL & Medical Society Engagement
・High Medical Needs & HBD Program Involvement
・Orphan Designation
・Regulatory File Submission
・Q&A to Approval

Reimbursement

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

Quality & Operations

・QMS Development & Maintenance
・Marketing Authorization Holder (MAH) Services
・Designated Marketing Authorization Holder (DMAH) Services
・Importation & Market Release
・Labeling & Repackaging
・Warehousing & Logistics

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
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MAH/DMAH services to enable foreign manufacturers
to proactively enter Japanese market for MedTech products

Since overseas manufacturers without networks in Japan cannot assume the role of a distributor with a business license (i.e., license holder) required for sales of MedTech products in Japan, they generally either 1) conclude an exclusive distributor agreement with a Japanese distributor with a business license, or 2) establish a Japanese corporation by investing heavily in personnel (establishing a general manufacturing and sales manager, safety manager, and domestic quality operations manager) and infrastructure to fulfill the requirements. Therefore, they generally either 1) enter into an exclusive distributorship agreement with a Japanese distributor that has a business license, or 2) establish a Japanese subsidiary with a significant investment in personnel (a general manufacturing and marketing manager, a safety manager, and a domestic quality operations manager) and infrastructure to fulfill the requirements.

By establishing a MAH (Manufacturing and Marketing Authorization Holder) or DMAH (Designated Foreign Marketing Authorization Holder), an overseas manufacturer can realize a sales strategy from a more leading position while reducing the initial investment in establishing a Japanese corporation.

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.

Advantages of outsourcing for MAH/DMAH service

In order to deploy your medical device in Japan, the following items must be fulfilled:
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
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The main roles of MAH/DMAH are as follows:

・Application and registration for regulatory approval procedures and other business licenses necessary for domestic sales

・Import, storage, shipping inspection, and distribution management of products

・Quality control operations based on the QMS ordinance

・Post-marketing safety management operations based on the GVP ordinance

Fee

Fixed monthly (license fee) system

  • 1. general manufacturing and marketing operations
    Quality management operations (QMS operations) Safety management operations (GVP operations)

    2. 1 set per item (e.g., 3 sets of license fee for 3 items)

    *The "license fee" does not vary depending on the quantity purchased or the total invoice amount.

    The "license fee" is based on the nature of the product, the failure rate based on risk analysis, and the number of shipments per year,
    The "license fee" is determined upon consultation with the customer.
  • MAH/DMAH license fee + costs for receiving, inspecting, packaging, labeling, enclosing attachments, storage, inventory control, etc.
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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 MAH/DMAH 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
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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。
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