Compliance and market access
Compliance and market access
Powered wheelchairs are regulated medical devices in most export markets. We supply the technical file, test reports and labelling your authority requires.
Compliance and market access
| Market | Classification | What is required | Typical lead time |
|---|---|---|---|
| United States | Class II medical device | FDA 510(k) clearance, establishment registration, UDI, FCC / EMC | 6-12 months |
| European Union | MDR Class I (Class IIa for some configurations) | CE marking, EN 12184 testing, ISO 13485, EU Authorised Representative | 3-6 months |
| United Kingdom | UKCA | UKCA marking (CE accepted during transitional windows) | 2-4 months |
| Australia | TGA regulated | ARTG inclusion, Australian sponsor | 2-4 months |
| Canada | Health Canada Class II | Medical Device Establishment Licence (MDEL) | 3-6 months |
Classification depends on the final configuration and intended use. We confirm the route with your notified body before production.
Lithium battery and shipping
All models ship with UN 38.3 tested cells. Chairs are declared as UN 3171 (battery-powered vehicle) or UN 3481 (battery packed with equipment) depending on pack configuration - we book dangerous-goods lanes, never general cargo.
Accessibility commitment
This site is built to WCAG 2.1 AA: keyboard navigable, screen-reader tested, and readable at 200% zoom without loss of content.
Certification
- CE EU MDR 2017/745
- FDA US Class II device
- ISO 13485 Medical device QMS
- EN 12184 Powered wheelchair standard
- UN 38.3 Lithium battery transport