We "Advance Japan with Medical Devices" Co. Ltd. (AJMD K.K.), take care of your product certification in accordance with the Ministry of Health Labour and Welfare and the Japanese Pharmaceuticals Medical Device Act. (PMD Act.).
We are registered under license No. 13B1X10231 as (Designated) Marketing Approval Holder (MAH / DMAH) for medical devices of any kind for medical devices of all classes I to IV (according to Japanese standards).
Mr. Koepke has more than 15 years of experience in Quality Management, Service and Regulatory Affairs in Germany and Japan. He established AMDJ K.K. in 2011 in Tokyo as a Service Provider targeting foreign medical device manufacturers to successfully register, import and market their medical devices to Japan. The rights of the product licenses are fully kept by the manufacturer.
Due to his knowledge of the Japanese environment and the difficulties and barriers that encounter foreign manufacturers when it came to enter on the Japanese medical market, Mr Koepke and his team decide to provide additional services as consulting and marketing to assure the success of his customers.
Together with his team of international experienced engineers and marketing specialists AJMD K.K. consists of decades of experiences in the Japanese medical market.
Essential requirements to enter the Japanese medical market
Foreign Manufacturing Company
QMS system according to ISO 13485, or ISO 9001 (only for class I products sufficient)
FMR (Foreign Manufacturing Registration)
MAH / DMAH for product licensing
Importer (MAH / DMAH)
Storage service for your device.
Translation service for your manual and marketing material.
Technical service for your device. Training for dealer, installation.
Sales support. This includes searching for suitable dealer for your medical device.
Contacting these dealer and negotiate the sales condition according to your advice.
Marketing support. Including market research, market overview, price finding for your medical device. Prepare and conduct presentation.