DMAH (Designated Marketing Approval Holder)
Accelerate Your Entry into Japan's Growing CAD Market with Minimal Initial Investment
Japan’s Computer-Aided Detection (CAD) market is developing rapidly, leading other countries. Major medical institutions, including university hospitals, can benefit from insurance coverage for AI management systems. Even without insurance coverage, community hospitals and clinics are actively implementing AI solutions on their own initiative, driving remarkable growth in Japan’s CAD market.
Foreign manufacturers without a base in Japan need substantial time and costs to sell medical devices as an MAH, including establishing a Japanese corporation, complying with Japan-specific regulations, and completing medical device approval procedures. However, by utilizing a Japanese DMAH (Designated Marketing Authorization Holder), these operations can be outsourced to the DMAH, allowing foreign manufacturers to quickly enter the market without establishing a Japanese corporation. This significantly reduces initial investment and streamlines business development.
| Tasks | Manufacturer as MAH | Using DMAH |
|---|---|---|
| Establishment of Japanese Corporation | ○ | ― |
| Appointment of Three Qualified Staff Positions (General Marketing Director, Domestic Quality Assurance Manager, Safety Control Manager) | Foreign Manufacturer | Plusman |
| Establishment of Internal Systems for Compliance with Japan-specific QMS and GVP Ordinances | Foreign Manufacturer | Plusman |
| Obtaining and Maintaining Business Licenses, Responding to On-site Inspections | Foreign Manufacturer | Plusman |
| Application and Renewal Procedures with PMDA/Certification Bodies | Foreign Manufacturer | Plusman |
| Post-market Safety Management Operations | Foreign Manufacturer | Plusman |
| Tasks | Manufacturer as MAH | Using DMAH |
|---|---|---|
| License Holder | Foreign Manufacturer | Foreign Manufacturer |
| Company Name Listed on Package Insert | Foreign Manufacturer | Plusman And Foreign Manufacturer |
| Provision of Information Required for Approval Application to DMAH | ― | Foreign Manufacturer |
| Establishment and Maintenance of DMAH System (Creation of Agreement) | ― | Plusman And Foreign manufacturer |
| Selection of Sales Distributors and Management of Sales Strategy | Foreign manufacturer | Foreign manufacturer |
| ○ | Reduced Initial Investment | No need for initial local investment such as establishing a Japanese corporation, hiring qualified personnel, or obtaining MAH business licenses. |
| ○ | Quick Sales Launch | Device approval requires strategies based on understanding Japanese review criteria. Choosing a DMAH with experience in regulatory compliance for specific products leads to smooth approval. |
| ○ | Reduced Regulatory Burden | All procedures, from regulatory applications to post-market operations, are handled through the DMAH. |
| ○ | Maintain Commercial Independence | PMDA and certification bodies grant approval (certification) to foreign manufacturers, and devices are registered under the foreign manufacturer's name. Foreign manufacturer maintains complete control over sales strategy in Japan. |
Plusman has experience with chest CAD device regulatory affairs and assists foreign-developed CAD systems in entering the Japanese market.
ü Holds Class II Medical Device Marketing Authorization License and provides DMAH functions.
ü Has experience in obtaining certification for chest CAD medical devices and specializes in regulatory affairs for AI medical devices and CAD products.
ü Plusman has multiple collaborative research achievements in radiology. We can support clinical implementation utilizing our strong network with KOLs.
※Note: We feature an interview with the current president of the Japan Radiological Society, a leading expert in medical AI (Link)