Selling Medical Devices in Canada - Distributor? Private Label?

katastic2908

Involved In Discussions
#1
Hello,

The company I work for is not ready to switch over to MDSAP, so we have chosen to forgo our Canadian Licenses since we really haven't sold enough there to justify the additional expense of a MDSAP audit. We have a distributor in Canada that is asking the following:

"As your company is not willing to upgrade its ISO 13485 CMDCAS certification to MDSAP, I am suggesting your company provides the full technical file documents to my company then we can include it in our MDSAP registration so we will be able to get a new MDL (medical device license) for these products from Health Canada under my company brand.

This will require an OEM basis agreement between our companies so the products will be made with my company brand (labeling)."


What are your thoughts? Is this ok to do? What risks should we consider? Anything you can add would be most appreciated. If it is ok to do, if you can provide a link or reference to the canadian document that says that, that would be appreciated as well.

Thank you
 
Elsmar Forum Sponsor
#2
Hello katastic,

Our company sells medical devices on a OEM/Private Label basis globally and there is nothing generally wrong with entering into these agreements provided you protect yourselves. However, my reading of the information regarding Health Canada's transition to MDSAP is that your distributor cannot qualify for MDSAP (hence, must cease to sell your product - stockpiling not allowed) without your cooperation as it is the manufacturer who gets the certificate, not the distributor.

Please see Q7: Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ) - Canada.ca

Please excuse my unsolicited inquiry and advice but why is your company "not ready" to proceed with MDSAP? We certainly were not ready, either and it took me many months of convincing to get everyone on board with MDSAP. In the end, the process was pricey but not that arduous. If costs are the problem, then maybe your distributor, upon finding out they must discontinue your device if you don't qualify for MDSAP, will be willing to provide some support - perhaps in exchange for credits down the road or some other low cash-impact methods of financing.
 

Edward Reesor

Trusted Information Resource
#3
As a Canadian manufacturer of medical devices with MDSAP certification, I have considered doing something similar, i.e. taking a non-MDSAP certified product and incorporating it as one of our products as a private labeled device. This allows access to the Canadian market without the actual manufacturer having to undergo the MDSAP program itself (another discussion on this forum discusses how the mandatory MDSAP program by Health Canada is driving foreign products from our markets).

What I am reading is that they already have MDSAP certification and are willing to add it to their Health Canada licenses as a private labeled device of their own. In order to do that, they will need all the technical files that go along with licensing a medical device as if it was their own. I would suggest a NDA agreement in order to solidify and protect your IP. There may be added costs associated with them getting it licensed, however those may be offset by your cost savings by withdrawing from Canadian CMDCAS registratrion. You may have to consider a price adjustment for their work and involvement in getting it back on the market.
 
#4
As a Canadian manufacturer of medical devices with MDSAP certification, I have considered doing something similar, i.e. taking a non-MDSAP certified product and incorporating it as one of our products as a private labeled device. This allows access to the Canadian market without the actual manufacturer having to undergo the MDSAP program itself (another discussion on this forum discusses how the mandatory MDSAP program by Health Canada is driving foreign products from our markets).

What I am reading is that they already have MDSAP certification and are willing to add it to their Health Canada licenses as a private labeled device of their own. In order to do that, they will need all the technical files that go along with licensing a medical device as if it was their own. I would suggest a NDA agreement in order to solidify and protect your IP. There may be added costs associated with them getting it licensed, however those may be offset by your cost savings by withdrawing from Canadian CMDCAS registratrion. You may have to consider a price adjustment for their work and involvement in getting it back on the market.
Hello,

The company I work for is not ready to switch over to MDSAP, so we have chosen to forgo our Canadian Licenses since we really haven't sold enough there to justify the additional expense of a MDSAP audit. We have a distributor in Canada that is asking the following:

"As your company is not willing to upgrade its ISO 13485 CMDCAS certification to MDSAP, I am suggesting your company provides the full technical file documents to my company then we can include it in our MDSAP registration so we will be able to get a new MDL (medical device license) for these products from Health Canada under my company brand.

This will require an OEM basis agreement between our companies so the products will be made with my company brand (labeling)."


What are your thoughts? Is this ok to do? What risks should we consider? Anything you can add would be most appreciated. If it is ok to do, if you can provide a link or reference to the canadian document that says that, that would be appreciated as well.

Thank you

Hi, we are i the same position, did you have any progress on that which you are willing to share.
We are also looking into same solution.
would appreciate if you can share wit me.

many thanks

Ziv
 

DannyK

Trusted Information Resource
#5
I have helped many Canadian distributors get ISO 13485:2016/MDSAP certification and this allowed the original manufacturers to still sell into the Canadian market. The difference being is that the name on the label is of the "distributor" who is now considered the "manufacturer".
The main requirements are to complete a quality agreement and transfer or make available the technical files. The process is fairly simple as long as the original manufacturer has ISO 13485:2016 quality system from an accredited registrar.
 
#6
I agree that the process would be the same as having a legal manufacturer (previously known as an OBL).
The question is, are there any known legal manufacturers offering such service to small/ medium companies who are looking for such solution.
Having the MDSAP plan implemented is not rational for small companies.
 

DannyK

Trusted Information Resource
#7
I agree that the process would be the same as having a legal manufacturer (previously known as an OBL).
The question is, are there any known legal manufacturers offering such service to small/ medium companies who are looking for such solution.
Having the MDSAP plan implemented is not rational for small companies.
I know of several distributors who may be interested. It all depends on the type of products and target market.
I deal with distributors that sell to pharmacies and others that sell to hospitals and clinics..
Please send me a PM for more information.

Danny
 
#8
I know of several distributors who may be interested. It all depends on the type of products and target market.
I deal with distributors that sell to pharmacies and others that sell to hospitals and clinics..
Please send me a PM for more information.

Danny
Hi Danny,

can you share your contact info.

Thanks
 

DannyK

Trusted Information Resource
#9
It would not be appropriate to share company names.
Please send me a PM with the types of products they are offering.
I will then ask the distribution companies that have MDSAP if there is any interest.
There has to be a financial incentive for the distribution companies to sell the products.
After I will get back to you or the company.
 
#10
Hi Danny,

I am unable new to the forum and I currently unable to send private messages. Are you able to help me with MDSAP implementation? Can you send me an email on [email protected] so I can start communicating with you?

Thanks,
Atif
 
Thread starter Similar threads Forum Replies Date
M Selling Medical Devices in Puerto Rico US Food and Drug Administration (FDA) 3
S Selling Medical Demo Devices - is it allowable? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Selling Medical Devices from the US into Israel Other Medical Device Regulations World-Wide 2
JoCam Buying and selling Class I and II medical devices EU Medical Device Regulations 1
B Selling Medical devices to Iran - OFAC doubts Other Medical Device Regulations World-Wide 6
S Manufacturing and Selling Medical Devices with Used Components ISO 13485:2016 - Medical Device Quality Management Systems 3
E Documentation for selling Prescription Only Medical Devices Other Medical Device and Orthopedic Related Topics 8
B Selling Class IIa Medical devices in Albania Other Medical Device Regulations World-Wide 1
I Selling Over the Counter Medical Devices in France EU Medical Device Regulations 3
A Selling Medical Devices and/or Accessories Online US Food and Drug Administration (FDA) 11
I Requirements for selling Class I Medical Devices in Canada ISO 13485:2016 - Medical Device Quality Management Systems 4
S Re-selling off-the-shelf (OTS) accessories for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Regulatory Requirements are for selling Medical Devices in the Ukraine? Other Medical Device Regulations World-Wide 9
I Selling medical gown and mask in China China Medical Device Regulations 0
N Selling a class II Medical Device in Canada in Pharmacies Elsmar Xenforo Forum Software Instructions and Help 10
K Selling Medical Device Components to US hospitals and doctors US Food and Drug Administration (FDA) 4
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
D Selling Medical Device Abroad After the Expiring Date of the EC Certificate EU Medical Device Regulations 5
B Selling with a Medical Device App EU Medical Device Regulations 4
T New to WEEE Directive - Selling a medical device directly to a professional end-user RoHS, REACH, ELV, IMDS and Restricted Substances 1
N Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M Selling Medical Device DTC in FL - Need a license? Other US Medical Device Regulations 1
M Class I Medical Device - Need to notify CA (Competent Authority) if selling in Asia EU Medical Device Regulations 4
R Selling of Medical Power Supply in Australia/New Zealand and Japan Other Medical Device Regulations World-Wide 5
B Additional requirements for selling Class I Medical Device in Poland EU Medical Device Regulations 3
G Selling a CE mark Class I Medical Device in Sweden - Any other requirements? EU Medical Device Regulations 13
C Labeling requirements when selling demo Medical Device equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G Medical Device Pre-Selling and Conference Posters while awaiting Approval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N Perfect Selling Fully Functioning Class 1 Medical Device vs. Antique ISO 13485:2016 - Medical Device Quality Management Systems 10
D Selling Class IIa medical device (sterile syringes) in USA ISO 13485:2016 - Medical Device Quality Management Systems 2
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Selling clinical practice advice Other US Medical Device Regulations 4
C Does the company violates any regulation/standard by selling device without warranty ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
T RISK: Selling Diagnostic Devices on Amazon Manufacturing and Related Processes 0
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
T MDSAP readiness - Selling clinical product IVDs into Canada Canada Medical Device Regulations 7
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7
W Legality of selling parts by count - Counting Scales Quality Manager and Management Related Issues 6
B What is the FDA guidance regarding selling replacement parts and traceability? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D What are the requirements for selling Alcohol Swabs in USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Marc LinkedIn Accused Of Secretly Selling Members Professional Data To Potential Employers World News 9
C Selling of Research products in Europe EU Medical Device Regulations 9
G QMS - Selling the idea to the CEO! Quality Manager and Management Related Issues 8
S Regulations for Selling Convenience Kit vs. Selling Separate Parts Other US Medical Device Regulations 2
S Selling a CE Marked Product to a Hospital in Bulgaria Other Medical Device Regulations World-Wide 4
Ronen E ISO is Selling Draft Standards ISO 13485:2016 - Medical Device Quality Management Systems 7
Marc Boeing caught selling used parts as new to Pentagon (Oct 2013) World News 3
Q Internal Laboratory Services - Selling Services to "Outside" Customers General Measurement Device and Calibration Topics 1
M "Selling" the idea of using Work Orders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Similar threads


















































Top Bottom