It is our understanding that in order to sell a US class 1 device in Canada it is necessary for either us or our potential distributor to have an establishment license.
Canada licenses both Drug Establishments and Device Establishments. If a potential distributor already has a Drug Establishment license must they also obtain an additional Device Establishment license in order to import and sell a device?
Thank you in advance for any input.
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Charles Cosner
Regulatory Affairs Manager
Bioderm, Inc.
Largo FL
United States
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