Many orthotic, prosthetic and rehabilitation devices are Class I or Class II with the US FDA, and a large share are exempt from premarket notification. Getting the classification right is the difference between a simple listing and a 510(k).
United States
- Product code and classification review
- Establishment registration and device listing
- 510(k) premarket notifications where required
- US Agent services for foreign manufacturers
- Quality systems under the FDA Quality Management System Regulation (QMSR), which aligns US requirements with ISO 13485 and took effect on 2 February 2026
- Labelling, UDI and complaint handling
- Consumer product safety for non-medical items
Canada
- Medical Device Establishment Licence (MDEL) for importers and distributors
- Medical Device Licence for Class II devices and above
- ISO 13485 certification under MDSAP
Talk to us about North America
Tell us your device, its classification today and where it is already approved, and we will map the fastest compliant route.
