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Medical Device and Healthcare Technology 

Market Entry Implementation and Consulting

Our Expertise

Learn More About Japan

Foreign Firms Must Act Fast

Approval Consulting and Service

Updated May 2021

Japan has strong demand for healthcare technologies and medical devices. Parkdale Group helps you find the path through the regulatory process distribution system, and to the end users. Class I and Class II and some Class III devices usually straight forward pathway to approval. Contact us today to see how Parkdale Group can help you. 

For many Class III or Class IV devices, the regulatory hurdles can be more demanding. Big Questions include the necessity for Clinical Trials, or the sufficiency of data on hand for an approval application.

Parkdale Group, along with our trusted partners in Japan, can undertake the Initial Consultation Meetings with the PMDA, before you need to make the total commitment to the approval process. This unique service clarifies the approval pathway, and saves you time and headaches in the long run. 

There is no cookie cutter approach to Japan, and new and innovative approaches can make all the difference. We can even help you approach the regulator in advance to make sure that you have a smooth and effective approval process. Send a message to info@parkdale-group.co.jp today to learn more. 

Make It Happen

Finding the Right Partners--MAH and DMAH

Marketing Authorization Holder--DMAH or the MAH are critical to your entry to Japan. 

 

Parkdale Group put together with the best DMAH or MAH for you and your technology.  

Having the right partner in Japan will make all the difference in shortening the time to approval, and getting your devices or technology to end users. 

Make the most of your entry to the huge and sophisticated Japanese market by contacting us today. 

Market Entry and Long Term

Support

Company Set Up and Long Term Support

Parkdale Group develops your business in Japan. 

We connect you with Regulatory and Market Experts, distributors and re-sellers to help you grow in Japan.

Contact us today to learn more about the Japan market and Parkdale Group Inc. 

Contact Philip O'Neill at philip.oneill@parkdale-group.co.jp 

 

Contact Us

Get In Touch

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Head Office

Kyoto Research Park

134 Chudoji, Shimogyo-ku, Kyoto, Japan, 600-8815

京都リサーチパーク

〒600-8815 京都府京都市下京区中堂寺南町134

Parkdale Group Inc.

Registered Address: 9-20 Hananobocho, Murasakino, Kita-ku, Kyoto, 603-8302 Japan

本社:〒603−8302京都市北区紫野花ノ坊町9番地20

パークデールグループ株式会社、京都

E-mail: philip.oneill@parkdale-group.co.jp

Phone: 81-80-1450-8480