Total support for Medical devices Regulatory affairs in Japan

Medical Lab Partners is consulting company for the development and regularoty registration of innovative medical devices. The well-experienced and special experts in Development, Regulatory Affairs, Quality Management, and Marketing are ready to support your development of medical devices. Our main customers are material makers, automotive parts makers, metal processing makers, stationery makers, mechanical makers, software company and others from various industry. Also we can support the device in many fields such as: surgical tools, device for the treatment of blood and cells , software, rehabilitation, neurosurgical and orthopedic tools, diagnostic devices and so on.

Our Mission

Medical Lab Partners contributes to anyone in disease for their wellness life through the research and development of innovative medical devices.

Company Profile

Services

Medical Lab Partners provides comprehensive, one-stop assistance in commercialization of medical devices.

・Market Research in Japanese medical fields

・ Regulatory affairs for the registration of medical devices and foreign manufacturers

・Consulting services for development medical devices and for PMDA consultation meeting

・Designated Marketing Authorization Holder (DMAH) Service

Registration a foreign product as a medical device in Japan

For regulatory approval of foreign products as a medical device in Japan, Establishment of distribution system as well as device applications is required.

For establishment of distribution system, Determination of Determination of Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH), foreign manufacturer registration, QMS conformity assessment, and warehouse manufacturer registration are required. In addition, distributor must be determined for distribution.

Points of regulatory approval

Establishment of Foreign special approval system

To register a foreign product as a medical device in Japan, Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH), and Accredited Foreign Manufacturer are needed. Medical Lab Partners provide DMAH service and registration support of the accredited foreign manufacturer.

Three ways of entry into Japanese medical device market*

1. Establish subsidiary in Japan and become MAH

2. Find MAH in Japan as an importer

3. Find Designated Marketing Authorization Holder (DMAH) in Japan

MAH act as a distributor and a regulatory responsible company for activities under QMS and GVP regulations.

DMAH act as a regulatory responsible company for activities under QMS and GVP regulations.

* Every foreign manufacturer of medical device is required to be accredited by the Minister of Health, Labour, and Welfare as an “Accredited Foreign Manufacturer”.

Why select DMAH?

- You can launch your product with your brand.

- You can freely choose your distributors.

- You do not need to establish a branch office and to hire required managers for MAH in Japan.

- You can expand sales network and get more sales information.

MAH and DMAH system

Registration of your products

The regulatory process for medical devices in Japan differs according to the classification of the product.

When the product is a Class I product, submit documents summarizing data to PMDA and make a notification. When it is a Class II or Class III product with certification standards, submit documents to the registration certification body and receive certification. When it is a Class II or III product without certification or Class IV product, submit documents to the PMDA for approval.

The classification of product is associated with JMDN code.

Medical Lab Partners provides the services for registration of the products such as

- - Applicability of medical devices
  - Clarification of the requirements for application of medical devices
  - Support for making the documents for registration of medical devices.

Determining of regulatory process