Japan

Medical Device Consulting Services for Japan

Emergo Group helps medical device and IVD manufacturers obtain regulatory approval in Japan. We can help you with many Japanese quality assurance, regulatory compliance and distribution management issues. Our team can assist your company with medical device classification and preparation of your regulatory submission to the PMDA. With offices in Tokyo we can also act as your independent Designated Market Authorization Holder (MAH) regulatory representative in Japan. See below for a list of services for Japan.

Registration and Approval

In-Country Representation