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Feel free to contact us for medical device regulatory submissions, PMDA consultation, clinical evaluation, QMS compliance, and Japan market entry.

Information that helps us review your inquiry

01

Product information

Product overview, intended use, main design and specifications, and overseas regulatory and sales status

02

Current stage

Classification review, PMDA consultation, submission preparation, QMS readiness, or other work already underway

03

Questions and objectives

Requested support, expected schedule, and regulatory or technical issues identified so far

Consultation Form

You can contact us before product details or a submission strategy are finalized. Leave the JMDN code and device classification blank if they are unknown.

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