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. 

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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.

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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. 

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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 today to learn more. 

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