About Medical Lab Partners
Medical Lab Partners is consulting company for the development 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.
Medical Lab Partners contributes to anyone in disease for their wellness life through the research and development of innovative medical devices.
Medical Lab Partners provides comprehensive, one-stop assistance in commercialization of medical devices.
・Market Research in Japanese medical fields
・Consulting services for development products and Japanese regulatory affairs
・Designated Marketing Authorization Holder (DMAH) Service
Registration a foreign product as a medical device in Japan
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 can expand sales network and get more sales information.