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-house R & D, marketing, manufacturing, sales and post-sales follow-ups. We have achieved a significant number of newly registered in vitro diagnostic products and approvals of medical reimbursement in Japan.
We are the partner of choice to provide "One Stop Shop" services for IVD/CDx products.
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.
MBL is one of the top companies 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.
A Leader in New IVD Medical Reimbursement Approval
MBL is one of the few IVD manufacturers participating in SCRUM-Japan, a consortium established by Japanese core hospitals and pharmaceutical companies to deliver optimal medical care to every cancer patient.
Extensive KOL Network
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
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.
Applications for diagnostics to be covered by the health insurance system fall into three categories: E1, E2, and E3. E1 is diagnostics with previously existing measurement items and measurement methods, E2 is diagnostics with new measurement methods, and E3 is diagnostics with new measurement items. At MBL, we work with all three categories, but we are particularly strong in E3.
for the number of new IVDs Medical reimbursement approval
MBL is one of the few IVD companies participating in SCRUM-Japan. Industry-academia Nationwide 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.
Success Stories
A expedited review was recommended because of clinical necessity.
MEBRIGHT NUDT15 Kit
Quick approval of Multiplex assay
MEBGEN RASKET-B Kit
Want a list of all of the CDx projects we have helped get approved? Send us your information and we will send you the list!
MEBCDX AAV9 Test
Application and approval of CDx for Zolgensma in Japan
Frequently Asked Questions
Can we develop a CDx for our own medicines in Japan?
MBL can handle seamlessly- from assay system development, to application, manufacturing, and sales.
Can you develop and launch CDx concurrently with our drug approval?
MBL provides consultation for simultaneous release.
We want to measure a biomarker, but don't have the measurement system for it.
Based on a wealth of know-how in developing diagnostics, MBL will construct the optimal measurement system.
We want to sell diagnostics approved overseas in Japanese market.
Of course, only application work is available. Please leave it to MBL for manufacture and sales as well.
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.
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