We’re here to help you navigate through various international regulatory approvals by meeting with the appropriate regulatory agencies, overseeing testing requirements, preparing applications for approval, and marketing devices internationally.
Health Canada
- Regulatory Strategy Development
- Device Classification and Intended Use Development
- Development of Testing Plans
- License Submission Preparation
- Investigational Testing Authorization (ITA) Application
- Class II, III, and IV Medical Device License Applications
- Post-Market Studies
European Union Medical Device Regulations (EU MDR)
- Technical files development
- CE mark application preparation
- Help companies write reports for CE applications
- Manage Notified Body relationships
Pharmaceuticals and Medical Devices Agency (PMDA)- Japan
- Help companies find and connect with in-country caretakers for their regulatory needs
- Clarify Japanese medical device application requirements
- Develop PMDA applications and review test reports in collaboration with in-country caretakers
FDA-Japan Harmonization by Doing (HBD)
- Navigate PMDA and FDA communication
- Ensure studies meet requirements for both regulatory agencies
- Initiate HBD clinical studies based on approved IDE trials
Additional Reference Links:
Let’s Get Started
Contact us directly at [email] or submit the form below. Someone from Addwin will be in touch within two business days.