MDSAP required for Device Initial Importer/Distributor into Canada?

margadia

Starting to get Involved
#1
Hi All. The company I work for is an initial importer of class II and III devices. we do not manufacture, we have a 3PL that handles the receiving, storage, handling and distribution of the devices, we do not come into contact with the finished product, we just facilitate the sale and the delivery of the device from the 3PL location. We do have a QMS in place. We do have manufacturer trained field service technicians that install and perform routine service on the devices at customer sites when requested. All training, service visits details and info is retained and shared with the manufacturer. This is included in our Quality Manual. Of course, design and development and many aspects of 13485 are excluded. But we do maintain all complaint and event reports. My question is, to distribute in Canada, are we required to be MDSAP certified? Here in the states, we don't need 13485 or 9001, we maintain a QMS that is aligned with 9001 but we are not certified to either as we do not manufacture any devices. I know the company is interested in obtaining 13485 and MDSAP certification but I don't know that either is necessary and I guess I'm looking for info to help make this determination with my management team. Any help is appreciated! Thanks!
 
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DannyK

Trusted Information Resource
#2
If your company name is not on the label as a manufacturer, then you do not need MDSAP.
You can get ISO 13485:2016 but it is not a requirement for your activities.
Your customer may mandate this requirement.

I hope this helps.

Danny
 

margadia

Starting to get Involved
#3
Hi Danny, thank you for the response! I am new to this company and they have no previous knowledge of certifications or what is required of them from a regulatory perspective as it is a fairly new business. Prior to my hiring, they were using a regulatory consultant that has been modeling their QMS as if they were the manufacturer and had been advising them to get 13485 and MDSAP certified. I had explained multiple times how this wasn't necessary but as they have a long standing relationship with the consultant and I am brand new, I think their mindset is that the consultant gets paid to advise and she would know best. We are the exclusive distributor in the US (mfr is in EU) for all of our vendor's finished goods, some bear "Distributed By us" on labeling but we are not listed as the manufacturer whatsoever. I appreciate your feedback as I have been second guessing myself on this and wanted to get an outside perspective. Many thanks!
 

margadia

Starting to get Involved
#6
Here's another question if anyone can help, if the legal manufacturer is not licensed in Canada (and does not have MDSAP) but we were to get MDSAP, would we be able to sell their devices in Canada or does the legal manufacturer need to be licensed in order to do so?
 

DannyK

Trusted Information Resource
#7
The legal manufacturer can be your company. The legal manufacturer has to be identified on the label.
The original supplier would need to have ISO 13485:2016 and have an agreement with your company to share their information.
 

margadia

Starting to get Involved
#8
In that scenario, would we then be required to obtain both 13485 and MDSAP or just have the supplier sign the attestation? Would they be white labeling it to make us the manufacturer or could we still function as a private label medical device?
 

margadia

Starting to get Involved
#10
Right so then we would need to get certified and show compliance to all aspects of 13485 as a manufacturer, correct? Or are we able to continue to exclude design and production as we currently do?
 
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