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MBL

Accelerating Product Launches in the Japanese Market


MBL offers clinical diagnosis and research reagents that measure biomarkers such as disease related proteins and/or genes related to human diseases.

Over the past 50 years, we have been engaged in in-house R&D, marketing, manufacturing, sales and post-sales follow-up. We have achieved the top numbers of newly registered in vitro diagnostic products and approvals of medical reimbursement in Japan.



We are currently the only company providing "One Stop Shop" services for IVD/CDx products.

MBL White Paper

Download our White Paper to learn more about how we
can help you enter the Japanese Market.

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One Stop Shop


MBL has all the required business licenses for medical device manufacturing, marketing, and sales of IVD/CDx products and repairing of medical devices in Japan. We are uniquely positioned to support foreign manufacturers to entry into Japanese market.

#1 in New IVD Medical Reimbursement Approval


MBL is the top company in Japan to successfully get approvals of new listed national reimbursement in the past 10 years. 
We have many years of experience in PMDA regulatory affairs and clinical developments related to IVD/CDx products.

Extensive KOL Network

 


MBL is the only IVD manufacturer participating in SCRUM-Japan, a consortium established by Japanese core hospitals and pharmaceutical companies to deliver optimal medical care to every cancer patient.

Your Partner in CDx. Expert Support

From development through manufacturing and sales, we can help you enter the Japanese market quickly and easily through our full service support, experience in PMDA and regulatory affairs, and extensive KOL Network.

Full Service Support

From development to retailing and repairing we've got you covered. We can take you through the process from beginning to end, or you can leverage any of our experience in specific activities. Our process is flexible and customized for your needs.

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#1 in Japan for Approvals

Extensive PMDA Experience. One of our major strengths is our many years of experience in PMDA regulatory affairs and clinical developments related to IVD/CDx products.

MBL has achieved the top number of newly registered in vitro diagnostic products and approvals of medical reimbursement in Japan in the past 10 years.

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KOL Network Benefits

THE ONLY IVD COMPANY participating in SCRUM-Japan. Industry-academia nation-wide cancer genome screening project "SCRUM-Japan" is the world’s most advanced project of genetic alteration screening project for patients with cancers.

Managed by the National Cancer Center Hospital East in collaboration with medical institutions and pharmaceutical companies all over the country, the aim is to provide the best medical care to every patient.

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Success Stories

mbl1 (1)

MEBCDX AAV9 Test

Application and approval of CDx for Zolgensma in Japan

MBL2 (1)

MEBRIGHT NUDT15 Kit

A expedited review was recommended because of clinical necessity.

MBL3 (1)

MEBGEN RASKET-B Kit

Quick approval of Multiplex assay

Frequently Asked Questions

Get Help entering the Japanese Market Today

We can walk you through the entire regulatory process, provide a list of CDx initiatives we've helped with in the past and answer any questions you have about our services.