Registration and Licensing

What each regime requires a device business to file with the regulator, and what it requires for each device. The US requires establishment registration and device listing. The EU requires registration of manufacturers, authorized representatives, importers, and devices in an electronic system. Canada requires establishment licenses and medical device licenses.

Where it is written

21 CFR 807.20; Regulation (EU) 2017/745, Articles 29 to 31; Medical Devices Regulations (SOR/98-282), sections 26 and 44

Also called

establishment registration, device registration

Regimes

• Registration and ListingTwo linked FDA requirements. Owners or operators of device establishments register the establishments and list the devices they have in commercial distribution.
• Registration (EU)Before placing a device on the market, a manufacturer, authorized representative, or importer registers in the EU electronic system and receives a single registration number (SRN). The manufacturer also assigns each device a Basic UDI-DI and provides it to the UDI database. Changes to the registration must be updated within one week.
• Licensing (CA)Canada requires an establishment license to import or sell a medical device, with exceptions for retailers, health care facilities, and certain manufacturers. No one may import or sell a Class II, III, or IV device unless its manufacturer holds a medical device license for it.

Related terms