Looking for a CDx Partner in Japan?
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.

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

2. New Product Development

for the number of new IVDs medical reimbursement approval

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.

Number of category E3 diagnostics covered
by the health insurance system from Feb 2003 to Feb 2023

Success Stories

CASE 1

The latest approved CDx

Application and approval of CDx for Zolgensma in Japan

MEBCDX AAV9 TEST

CASE 2

49 mutations detected at once

Quick approval of Multiplex assay

MEBGEN RASKET-B Kit

CASE 3

Quick approval

A expedited review was recommended because of clinical necessity.

MEBRIGHT NUDT15 Kit

CASE 4

The first approved CDx in Japan

Development of FCM-based CDx in half years

CCR4 Protein Detection Kit (FCM)

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

Success Stories

Quick approval of Multiplex assay

MEBGEN RASKET-B Kit

"ISO 13485" Certification

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