Product information
Product overview, intended use, main design and specifications, and overseas regulatory and sales status
CONTACT
Contact Us
Feel free to contact us for medical device regulatory submissions, PMDA consultation, clinical evaluation, QMS compliance, and Japan market entry.
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.
CONSULTATION GUIDE
Information that helps us review your inquiry
Current stage
Classification review, PMDA consultation, submission preparation, QMS readiness, or other work already underway
Questions and objectives
Requested support, expected schedule, and regulatory or technical issues identified so far
Consultation, quotations and commissioned work
Consultations and quotations are free of charge. We review your product’s features, available materials and progress to date, discuss the issues and support needed in detail, and propose the scope, fees and approach. For regulatory consultations, we also consider potential application routes. No consultation fee applies until you formally commission the work, including for questions after receiving a quotation.
Work such as preparing formal assessment reports or application documents starts after you agree to the scope and fees and formally commission the work.
What happens after your inquiry
- Inquiry and sharing product information
- Review of materials and detailed consultation
- Proposal of scope, approach and quotation, followed by questions and discussion
- Start of the agreed work after formal commissioning