Looking for a CDx Partner in Japan?
Contact MBL!

MBL was founded in 1969, and since then has offered 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 the top numbers of newly registered in vitro diagnostic products and approvals of medical reimbursement in Japan. So, we are the only one company providing "One Stop Shop" services for IVD/CDx products.

One-stop support covers development through manufacturing, sales.
You can leave flexibly whatever you want.

  MBL Company Ⅰ Company Ⅱ Company Ⅲ
Development
Clinical performance trial
PMDA approval
Insurance listing
Manufacturing
Retailing
Repairing
comparison table

Feel free to contact MBL!

1. One Stop Shop

Japan does not have an LDT framework.
In the United States, there is a framework for IVDs for medical reimbursement coverage by conducting tests in hospitals and reference laboratories using medical devices and reagents that have not been approved as in vitro diagnostics. Such a test is called a laboratory developed test (LDT). On the other hand, in Japan, basically, health insurance is not covered unless tests are performed using approved medical devices or in vitro diagnostic products.
Medical devices and diagnostic products are required regulatory approval based on the Pharmaceuticals and Medical Devices Law (PMDL) to enter the Japanese market. This law specifies that in order to sell medical devices in Japan, foreign manufacturers must first be registered as an accredited foreign manufacturer. Next, they must make appoint with a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) to apply their products to the Pharmaceutical and Medical Devices Act (PMD Act). These MAHs and DMAHs are obligated to perform quality control based on QMS and post-marketing safety management based on GVP, as well as various other operations such as product application.
MBL has all business licenses for medical device manufacturing, marketing, and sales of IVD/CDx products and repairing of medical devices. So we can strongly support foreign manufacturers to entry into Japanese market.


  MBL Company Ⅰ Company Ⅱ Company Ⅲ
Development
Clinical performance trial
PMDA approval
Insurance listing
Manufacturing
Retailing
Repairing
comparison table

One-stop support covers development through manufacturing, sales. You can leave flexibly whatever you want.

2. The highest in Japan

for the number of new IVDs medical reimbursement approval

One of our major strengths is that we have many years of experience in PMDA regulatory affairs and clinical developments related to IVD/CDx products. In particular, MBL is the top company to successfully get approvals of new listed national reimbursement in the past 10 years.

Number of new listed in the national reimbursement

reimbursement graph

Success Stories

CASE 1
The latest approved CDx

Application and approval of CDx for Zolgensma in Japan

MEBCDX AAV9 TEST
MEBCDX AAV9 TEST
CASE 2
No.1 Sales in Japan

Quick approval of Multiplex assay

MEBGEN RASKET-B Kit
MEBGEN RASKET-B Kit
CASE 3
Quick approval

A expedited review was recommended because of clinical necessity.

MEBRIGHT NUDT15 Kit
MEBRIGHT NUDT15 Kit
CASE 4
The first approved CDx in Japan

Development of FCM-based CDx in half years

CCR4 Protein Detection Kit (FCM)
MEBCDX AAV9 TEST

Reliable with proven MBL

3. Strong relationship with KOLs

In Japan, in order to widely disseminate drugs and medical devices, applying for regulatory affairs is not sufficient enough. They also need to be recommended, by authoritative doctors in each field.
For example, 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. MBL can anytime obtain advice from SCRUM-Japan, so that we does conduct appropriate clinical researches and regulatory affairs of IVD/CDx products. Also, through SCRUM-Japan, our medical devices can be launched on the market as recommended reagents by authorities.

"THE ONLY ONE IVD COMPANY" participating in SCRUM-Japan

SCRUM-Japan

The joint 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, undertaken by the National Cancer Center Hospital East in collaboration with medical institutions(>260) and pharmaceutical companies(12) all over the country, in the aim to provide the best medical care to every patient.

  • Medical institutions: >260
  • Pharmaceutical companies: 12
  • Clinical data base: >10,000 patients

MBL can support your business with
"a wide range of KOL network".

Only one company
among IVD makers

MBL
↓
Success Stories

Quick approval of Multiplex assay

MEBGEN RASKET-B Kit

MEBGEN RASKET-B Kit

"ISO 13485" Certification

  • SGS
  • UKAS

MBL supports you with an extensive network of KOLs!

FAQ

MBL can meet a wide range of needs.

We want to develop a CDx for our own medicines in Japan.

MBL can handle seamlessly from assay system development, to application, manufacture, 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 best 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.

Feel free to contact MBL!