Selling a class II Medical Device in Canada in Pharmacies

Eloisa0819

Registered
Hello,

Since your medical device is class II you have to obtain an MDSAP/ ISO 13485:2016 certificate to apply for a license with Health Canada.
The best way to sell quickly in Canada is to sell through a distributor that has MDSAP/ ISO 13485 and currently sells to pharmacies.
If you are interested, I can put you in touch with one of my clients, who sells directly to pharmacies.
You will have to obtain ISO 13485:2016 but it will be much less expensive and you won't have to wait in line to get an MDSAP audit.
Please send me a PM and I will direct you to my customer.
I have helped several customers that wanted access to the Canadian market but did not want to go through the expense of an MDSAP audit.
Hi! May I ask if you will be able to help me confirm if mobile scooters are considered as class 1 device please?
 
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