Launching Medical Device Products in Japan

What Does a Foreign Company Need to Do to Sell Its Medical Devices in Japan?

To sell a medical device in Japan, you need to complete the following four steps.

  1. 1) Register as a manufacturer
  2. 2) Register your product
  3. 3) Establish a quality management system (QMS)
  4. 4) Conduct post-marketing safety management

To complete these steps, you must undertake one of the following options:

  1. a) Establish a Japanese subsidiary for your company and register it as a Marketing Approval Holder (MAH);
  2. b) Allow a Japanese MAH to apply for the regulatory approval and licensing required to sell your company’s device; or
  3. c) Select a Japanese MAH to act as your Designated Marketing Approval Holder (D-MAH) and provide you with services related to importing and selling the device.

If you wish to pursue option b) or c), SunFlare can help you complete the required steps.
We can also provide you with a wide variety of other services, including consultation on device registration and market research, to support you in your efforts to enter the Japanese market and sell a medical device that has CE marking or FDA approval.

The parties responsible for carrying out the various steps for each of the options are indicated below.

Main steps Option a) Option b) Option c)
Registration as an MAH Japanese subsidiary of a foreign company Japanese MAH acts as a proxy Foreign company
Application for device registration Japanese subsidiary of a foreign company Japanese MAH acts as a proxy D-MAH acts as a proxy
Lead role in the implementation of a sales strategy in Japan Foreign company and its Japanese subsidiary Japanese MAH acts as a proxy in most respects Foreign company in most respects
Establishment of a QMS Japanese subsidiary of a foreign company Japanese MAH acts as a proxy Foreign company
Conducting of post-marketing safety management Japanese subsidiary of a foreign company Japanese MAH acts as a proxy D-MAH acts as a proxy

Main Services

Designated Marketing Approval Holder (D-MAH) services
Device registration and approval for the Japanese market
Establishment of QMS
Market research

Contact Us

SunFlare Co., Ltd. Tokyo Head Office:
  1. Tel: +81-3-3355-1383
  2. Mail: info@sunflare.co.jp
  3. Contact :Shinya Arikawa
  4. Please include the following at the start of the subject line: [MEDICA 2017].

About Us

Corporate Profile
Corporate Name SunFlare Co., Ltd.
Representative Director Hiroyuki Sasai
Established Aug 1971
Capital 95 million yen
Businesses
  • Medical device consultancy services
    Global regulatory affairs for medical devices, quality management system (QMS) design, Designated Marketing Approval Holder (D-MAH) services, and market research
  • Documentation
    Translation (industrial/technical, business-related, and patent),technical writing, medical writing,research, drug-registration support, patent application and filing support, localization, document design, and documentation consulting services
  • System solutions (documentation management)
  • Education (SunFlare Academy)
Offices
  • Tokyo Head Office:
    Shinjuku Hirose Bldg., 4-7 Yotsuya, Shinjuku-ku, Tokyo 160-0004, Japan
    TEL: +81-3-3355-1168 FAX: +81-3-3355-1204
  • West Japan Branch:
    Yodoyabashi Yamamoto Bldg. 10F, 4-3-22 Imabashi, Chuo-Ku, Osaka 541-0042, Japan
    TEL: +81-6-6233-6700 FAX: +81-6-6233-6701
  • North Japan Branch:
    Hachinohe Intelligent Plaza, 1-4-43 Kita-Inter Kogyodanchi, Hachinohe, Aomori 039-2245, Japan
    TEL: +81-178-21-2228 FAX: +81-178-21-2170
  • Overseas branches: Paris and Dalian