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Selling a class II Medical Device in Canada in Pharmacies

noanalyst

Starting to get Involved
#1
Hi All,

I am a US based inventor of a simple ENT device that has been classified as a class II device by Health Canada. We have not approached the FDA yet. I want the device to be sold through pharmacies in Canada. I have reviewed a lot of threads here. But my questions are....

1) What is the fastest way to sell into Canada. I would rather remain a US company for now. Can I sell directly from the US into Canada or is the distributor/private label route the best path for me?​
2) Can anyone recommend good distributors that I can begin preliminary discussions?​
3) Are there specific rules I should be aware of if I want the device sold through pharmacies only?​
Appreciate any responses.
 
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DannyK

Trusted Information Resource
#2
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.
 

noanalyst

Starting to get Involved
#3
Thanks for the info. So if you put me in touch with a distributor that has MDSAP/ISO 13485, and my contract manufacturer in the US is already ISO 13485:2016 certified, do I still need to obtain ISO 13485:2016?
 

DannyK

Trusted Information Resource
#4
Yes it helps. Do you have a technical file, complaint and feedback processes and risk management records?
If most of the work is done by the contract manufacturer then getting ISO 13485:2016 will not be difficult .
 

noanalyst

Starting to get Involved
#5
We do not have a technical file yet. We are right now in talks with another company to handle our Quality Management Systems (complaints, audits, feedback, risk management etc). So we will be working with an ISO 13485:2016 certified contract manufacturer and a quality management system company.
 

DannyK

Trusted Information Resource
#6
Is there a reason why you do not want to handle the QMS requirements yourself?
What is important is that the license holder has a quality management system.
It does not have to be complicated.
 

noanalyst

Starting to get Involved
#7
No particular reason at all. We are both newbies to med devices so we really don't know how simple or complex the QMS requirements are. So we decided to work with a company to handle that part for us. Do you know of a site that gives an overview of what exactly we need to document and record. I have also heard of QMS audits. Can that be managed by newbies as well?
 

DannyK

Trusted Information Resource
#8
OK I understand. Who's name will appear on the product label "as the manufacturer". The "manufacturer" will have to get MDSAP and ISO 13485 certification. I may be able to help if you are looking for a distributor in Canada that has MDSAP and may want to add it to their scope. The distributor may ask you to pay some of the costs involved. Please send me PM if you would like to talk directly.
 

noanalyst

Starting to get Involved
#9
Ok. Will PM you. But quick question. How does the distributor model work generally for an inventor/manufacturer such as myself. If I intend to retail the device at $50. What type of markup does a distributor typically want.
 

noanalyst

Starting to get Involved
#10
OK I understand. Who's name will appear on the product label "as the manufacturer". The "manufacturer" will have to get MDSAP and ISO 13485 certification. I may be able to help if you are looking for a distributor in Canada that has MDSAP and may want to add it to their scope. The distributor may ask you to pay some of the costs involved. Please send me PM if you would like to talk directly.
By the way, I don't think I can PM you because I am a new user
 
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