Overseas medical device manufacturers
One-stop support for regulatory filings and Japanese market development
Manufacturers considering entering the Japanese market
Has your product been approved in Japan?
- Specializing in PMDA transition of CE and FDA-acquired products
- Support from foreign manufacturer registration to domestic sales structure
- Flexible contract types and pay-for-performance models can also be introduced.
One of the biggest barriers to entry into Japan for equipment manufacturers outside of Japan is obtaining approval and certification under Japan's Pharmaceuticals and Medical Devices Law (PMDA and certification bodies).
Compared to other countries, Japan's regulatory application process is extremely rigorous in terms of required documentation and review process, and it is essential to have local experts on the ground.
MedRegi is one of the few specialized services in Japan that provide total support for the pharmaceutical application process necessary for foreign manufacturers to enter the Japanese market.
Benefits -Why MedRegi-
Why choose MedRegi Application?
Transition of PMDA application
Support for smooth preparation and submission of applications for Japan for products that have already obtained international certifications such as CE and FDA
Foreign Manufacturer Application Registration
Support for application schemes and QMS conformity surveys, which are difficult for foreign companies to handle on their own
Flexible contract structure and pay-for-performance
Support for results-based support with low initial costs
Coverage -Diverse Fields
Supports a variety of medical fields
MedRegi provides application support not only for cosmetic medical devices, but also for a wide range of product areas, including
- General medical equipment (diagnostic imaging, treatment equipment, etc.)
- In vitro diagnostic products (IVD)
- Ability to negotiate with PMDA and certification bodies
- Quick response and generous support
Aftercare -PostMarket Support-.
Support for development in the Japanese market after licensing
We can also handle market development after licensing.
MedRegi provides not only application support, but also domestic development support (e.g., developing sales partners, matching with partner companies, etc.) after obtaining approval/certification.
We provide support that takes into account "how to market your product after application," with the goal of establishing your product in the Japanese market.
Contact Us
Contact Us
online interviews
Correspondence from online interviews
MedRegi provides consultation services for overseas medical device manufacturers regarding the application of the Pharmaceutical Affairs Act to the Japanese market in the form of online negotiations.
Our team of experts, who are familiar with the application procedures with PMDA (Pharmaceuticals and Medical Devices Agency) and certification bodies in Japan, will provide detailed explanations of the steps to application, required documents, and points to keep in mind regarding the unique Japanese system.
Companies that have already obtained CE Mark or FDA approval, but have never applied to Japan before, or want to expand into the Japanese market without a distributor, can also consult with us with confidence.
Please feel free to request an online interview and we will guide you to the best application policy and support tailored to the characteristics of your product, your current situation, and your wishes.
Our staff is well versed in both global trends and the Japanese system, and will support your company's entry into the Japanese market.
