Questions on submission for a medical device

[ryuhouske]

Hi there,

I just stumbled upon this website as my company is a distributor and would like some insight on how this submission works. We have electrode pads for TENs machines that we are trying to sell in Canada. When I try to apply for a Class 2 license it requires to have a MDSAP. We have our own private label so do they require MDSAP?

It is confusing on what they are asking for and would like some assistance.

Thank you in advance.

 

[Nichole F]

If you are selling a device you do not manufacturer under your name you still need a medical device license. Here is a helpful excerpt from Health Canada's Guidance on Private Label Medical Devices

"Health Canada recognizes that certain businesses, typically those that retail products to the general public, sell medical devices under their own name or trademark while having limited or no control over the activities covered in the definition of a manufacturer (see Section 4.1 below). These manufacturers are commonly referred to as private label manufacturers. Although private label manufacturers may not undertake any of the activities outlined in the definition, they do fall within the definition of "manufacturer" since they sell medical devices under their own name and the tasks listed in the definition are being performed "on their behalf"; that is, on behalf of the private label manufacturer. Therefore, private label manufacturers and the devices that they market must comply with the requirements of the Medical Devices Regulations."

Since your company will fall under the definition of a manufacturer, you will need a medical device license. Unless you are located in Canada, you will need an MDSAP certificate. If you are located in Canada, you can leverage your CAN/CSA-ISO 13485 certificate (see SOR/98-282(32)(2)(f).

You will also need a written agreement between your company and the actual manufacturer along with a cross reference between your MDL and their MDL. I would read the abovementioned guidance. It is very informative.

 

[ryuhouske]

Hi Nicole, thank you for your response. Just need a clarification. If the Manufacture is in China but we are just a distributor. We have our own private label for the items. I have got several ISO 13485 certificates from the Manufacture. As this is my first time applying and I am not sure if we should go to the Class II route or the Private label Class II.

 

[Nichole F]

If you are not the owner of the device (i.e., creator of the DHF), you are the private label manufacturer and both your company and the company in China will need device licenses in Canada. If you want to purse a manufacturer's license, you will need the design dossier essentially. For example, class II devices require a biennial post market summary report to be created and updated. In that report, you will need to assess the change in risk based upon customer complaints, adverse events, CAPAs, NCs, design changes, etc. You likely do not have all of this information if you are not manufacturing the device. Additionally, the report requires the creator to determine if there is a change to the established benefit-risk analysis based upon the post-market data analyzed during the reporting period. If you do not own the design of the device, you likely do not have the full risk file. If you are the private labeller, you do not have to complete this report; it is completed by the actual manufacturer.

Unless you can get the full device file from the manufacturer, you will need to apply as a private label manufacturer and get a private label class II device license. Your supplier will need a manufacturer class II device license and an MDSAP certificate.

Health Canada will not accept an ISO 13485 certificate unless it is to the CA/CSA version of the standard. You are probably better off going for MDSAP which has been required to apply for a medical device license since 2019. The guidance does look like it has provision for private label manufacturers to not have a ISO 13485 certificate, however your manufacturer in China will need an MDSAP certificate to obtain the device license to which you must link your private label device license. Either way, unless you have an MDSAP certificate, your company is still subject to inspections by Health Canada. They can inspect even with an MDSAP certificate in place, but these are usually for-cause inspections.

If you are causing the device to be labelled with your company's name, you fall under the definition of a manufacturer under Health Canada's rules even if you do not partake in any actual manufacturing activities.

 

[cosmeticqg]

Hello All- somewhat related to this thread. Can companies import and quarantine medical devices in Canada while all the certificates and licenses are being issued? My org wants to have the product available for distribution in Canada while all the paperwork takes place. I know we would be shipping at risk, but would it be acceptable as long as we have controls in place?
Thank you!