Vorpal Approach

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Vorpal is a unique platform offering

virtual subsidiary services in Japan for international MedTech innovators

Vorpal offers expertise in market assessment, clinical, regulatory and reimbursement services, enabling companies to successfully enter Japan with their approvals under their own control. 

Vorpal offers importation, warehousing and distribution infrastructure to offer a unique virtual subsidiary platform for overseas MedTech companies wishing to sell in Japan without investing in their own direct organization.

Vorpal offers end-to-end solutions for success in Japan...

Opportunity Validation

  • Patient Population Definition

  • KOL Identification & Influencing

  • Treatment Landscape Clarification

  • Product Evaluation

  • Pricing Assessment

  • Opportunity Sizing

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

Quality & Operations

  • QMS Development & Maintenance

  • Designated Marketing Authorization Holder (D-MAH) Services

  • Importation & Market Release

  • Labeling & Repackaging

  • Warehousing & Logistics

Clinical Development

  • Clinical Trial Design

  • KOL Engagement & Site Selection

  • Clinical Operations & CRO Management

  • GCP Compliance Assessments

  • Post-Marketing Surveillance (PMS)

  • Clinical Research Support

Reimbursement

  • Reimbursement Strategy Formulation

  • Medical Society Engagement

  • Patient Group Engagement

  • Treatment Guideline Influencing

  • MHLW Engagement

  • HTA & Health Economic Analysis

  • Q&A to Acceptance

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

D-MAH gives you more independence in the Japanese medical device market

 

In Japan, a manufacturer must have a local address and certified organization in order to be a Marketing Authorization Holder (MAH = license holder) for an approved medical device.

Common options for a foreign manufacturer are to 1) entrust a local distributor to hold your license, or 2) invest in local infrastructure to obtain your own certification with 3 mandatory staff positions: General Production and Marketing Manager (Soseki)*1, GVP Controller (Anseki)*2 and QA Controller (Hinseki)*3.

*1  Abbreviated Japanese term for “Sokatsu-Seizohanbai-Sekinin-Sha”

*2  Abbreviated Japanese term for “Anzen-Kanri-Sekinin-Sha”

*3  Abbreviated Japanese term for “Kokunai-Hinshitu-Gyomu-Un’ei-Sekinin-Sha”

A third option is to appoint a qualified local D-MAH (Designated Marketing Authorization Holder) to maintain your approval in your name. This solution enables foreign manufacturers to minimize initial investment and maintain control over all strategic options.

※“Marketing Authorization Holder (MAH)” is the license holder for which the regulatory approval of medical device is granted. Distribution of medical device will not be allowed in Japan without the MAH, who is comprehensively responsible for the quality of the device, logistics and post-marketing safety management.

※“Designated Marketing Authorization Holder (D-MAH)” is similar to an MAH, having overall responsibility for the quality of the approved medical device, logistics and post-marketing safety management. A D-MAH is not the approval holder, but a Japanese local presentative acting on behalf of the foreign manufacturer. 

The main roles of a D-MAH are:

  • Undertaking regulatory approval submission, obtaining other business permissions necessary for domestic distribution

  • Management of product importation, storage, inspection and logistics

  • Quality management in accordance with QMS Ordinance

  • Post-marketing safety management in accordance with GVP Ordinance

Vorpal's D-MAH Services

  • Supporting a wide range of medical devices including Classes II-IV, specially-controlled medical devices, specially-designated medical devices requiring maintenance and In-Vitro Diagnostics (IVD)

  • Highly skilled and experienced regulatory and clinical experts for submissions of new and improved, higher class devices  

  • Bilingual and bicultural background staff ensure clear and efficient communication

Third Party Logistics

Foreign

Manufacturer

Sales

(Distributor)

PMDA/MHLW

RA/QA

Vorpal’s Roles & Responsibilities

Regulatory Actions:

•RA Services

•Data Gathering

•Field Services

•File Maintenance

•Japan Business Support

Logistics:

•Importation

•WH Management/Controlling

•Inspection & Market Releasing

•Transaction/Record keeping

•GVP monitoring & management

•Nonconformity Handling

•Return/Disposition Management

•others where necessary

Click here and contact us for further information.

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Nihonbashi Muromachi Bldg. 8F,

3-3-16, Nihonbashihongokucho, Chuo-ku, Tokyo 103-0021 Japan

© 2020 Vorpal Technologies K. K.​