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 Approval in Japan
Emergo can assist with medical device classification and preparation of your regulatory submission to the PMDA.
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.
Foreign Manufacturer Accreditation in Japan
Emergo Japan assists manufacturers in obtaining Foreign Manufacturer Accreditation from the PMDA.
Consulting for Companies Using Foreign Clinical Data for Medical Device Approvals in Japan
Our team in Tokyo can assist companies seeking to use data from clinical investigations conducting outside Japan to satisfy Japanese GCP regulations.
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.
Packaging Manufacturer Management in Japan
Japanese PAL states that labeling, packaging and warehousing are “manufacturing” activities. Therefore a Packaging Manufacturer License is required. We can help select and manage your chosen packaging manaufacturer.
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.
