Medical Device Consulting Services for Japan

Emergo Group helps medical device and IVD manufacturers obtain regulatory approval in Japan. We can assist you with many Japanese quality assurance, regulatory compliance and distribution management issues as shown below.

Japan Quality System Consulting to Meet MHLW Ordinance 169

We will assist you in implementing (or modifying) a quality system that meets Japanese PAL requirements.

Independent Designated Marketing Authorization Holder (MAH)

Emergo Japan K.K. can act as your independent MAH regulatory representative in Japan.

Medical Device Approvals and Pharmaceutical Affairs Law (PAL) Compliance

Emergo can assist with classification, document preparation, device testing and quality system audits.

Device Master File Creation for Japan - Seihin Hyojun Sho

Let Emergo prepare your Device Master File and other documents needed for Japanese medical device approval.

Summary Technical Document Compilation (STED)

Our consultants have broad experience preparing technical documents for Japan's PMDA.

Japan Medical Distributor Search

Let our team of specialists in our Tokyo office find and analyze the right distributors for your specific needs.

Medical Device Reimbursement in Japan

Once you have approval for your device, we can also assist with reimbursement strategy and approval.

English to Japanese Translation for Medical Device Documentation

If you are working with us on a project, we can assist with Japanese translation of your documentation.

View our Japanese language medical device regulatory affairs website.