successful registration of your medical device in Japan

Cobridge guides you to a more effective pathway for successful registration of your medical device in Japan.

Our Services

Cobridge supports medical device manufacturers in their entry into the Japanese market, specifically with regulatory affairs consulting services to apply for marketing approval of their products and with Designated Marketing Authorization Holder (DMAH) services to perform regulatory quality and safety control activities after approval.
Cobridge has the most comprehensive license, a first class DMAH license for Medical Devices and IVDs, which allows us to act as DMAH for Class II through IV medical devices and IVDs and thus serve for wide-range of clients and their products.

Advantages of Choosing Cobridge

Owning your own product approval allows you to have flexibility in the following ways:

  • Shielding of your confidential and proprietary technical information from your distributor that in many cases can become competitors, and
  • Flexibility in choosing multiple distribution networks

By designating Cobridge as your DMAH, you can take advantage of entry into the Japanese market with a cost-effective regulatory strategy.

If you have already entered in the market with a DMAH, changing your DMAH to Cobridge is also an option and changing DMAH is not difficult or time-consuming. As you see from the comparison table below, Cobridge will be your best choice.

Options for Entry into the Japanese Medical Devices Market

Options for Entry into the Japanese Medical Devices Market

There are three ways for foreign medical device manufacturers to obtain marketing approval in Japan.

  • Local office in Japan: Establishing a subsidary to apply for product marketing approval.
  • Distributor as MAH: Japanese medical device manufacturer which has Marketing Authorization Holder license (MAH) applies for an approval after receiving all the required information from the foreign manufacturer.
  • DMAH: Foreign manufacturer applies for approval via a DMAH by utilizing the "Foreign Special Approval System.

※ Each Class II through Class IV medical device is required marketing approval by the PMDA or a notified body in order to sell it in the Japanese market. In principle, only agents who has "Marketing Authorization Holder License for Medical Devices" in Japan can apply for and obtain an approval.

In case of 1) Local office in Japan: it is time-consuming, and costly staff and equip the subsidary as required to obtain relevant licenses and to operate.

In case of 2) Distributor MAH: Japanese medical device manufacturer which has MAH license and is often a potential competitor in Japan, applies for the approval.

As stated above, utilizing a DMAH may be suitable and most effective for foreign manufacturers that desire to control their approval.
This system allows a foreign manufacturer to own the product approval. Designating a DMAH that does not have product development and manufacturing functions like Cobridge will help protect your confidential and proprietary technical information.

  • Over 15-years' experiences as a DMAH of medical devices allow us to serve a wide-range of medical devices.
  • Our communication with clients is performed in English.
  • Our services are not merely to provide preparation of application dossiers, but to provide our clients with consulting services for the most cost effective regulatory pathway, including assistance in better understanding of Japanese regulations.

Our Experience

As DMAH currently more than 15 products
Medical Areas Orthopedics, Cardiovascular, Gastrointestinal, Ophthalamic, Dental, Neurological among others
Types of Medical Devices Electronic, single-use disposable devices (SUD), implantable medical devices, software-as-medical devices among others

Our experience of various products has involved over 300 clients worldwide

map:Our experience of various products has involved over 300 clients worldwide