Health Canada Private Label Guidance Confusion - Quality System Required?

[Mark Meer]

I've been reviewing the following Health Canada documents:

(1). Private Label Medical Devices Q&A
(2). Guidance Document - Private Label Medical Devices

My confusion is that (1) states:
"...the private label manufacturer does not have to submit ISO 13485/88 certification in order to apply for a private label device licence."

But (2) states:
"...private label manufacturers and the devices that they market must comply with the requirements of the Medical Devices Regulations."

So, by (2), private label manufactures would be subject to the Regulations (SOR-98-282):
"(f) a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03"

Is this not a contradiction? Most guidance documents (as well as posts here at the Cove) seem to indicate that private label manufacturers do not necessarily have to have 13485 QMS in place.
However, if private label manufacturers are subject to the CMDRs then it seems a 13485 QMS is a requirement...

 

[Mark Meer]

Re: Private label guidance confusion - Quality System Required?

Urg. My bad. Answered my own question

It seems from the wording that it would be acceptable for the private label manufacturer to provide the 13485 certificate of the original manufacturer (and hence not have to hold one themselves).

Followup question though:

The Private Label Guidance also states:
"Private label manufacturers that do not hold ISO 13485/13488 quality systems certificates under the Canadian Medical Devices Conformity Assessment System (CMDCAS) are subject to inspection by the Health Products and Food Branch Inspectorate."

What would such an inspection entail, assuming the private label manufacturer does not have a formal quality system in place?

 

[DannyK]

Inspections could include checking if the company is selling any other devices that are not licensed. Also they can check for labelling.
The main reason they would visit would be if there was a complaint or incident.

 

[Mark Meer]

Would the private label manufacturer be expected to have a formalized labelling process?

The Regulations don't seem to mention anything specific about control, only the contents...

 

[MIREGMGR]

For HC Class II, III and IV devices, a private label manufacturer must have an HC device license (of their own) to sell their device in Canada. The application for such a license must include an agreement by the original manufacturer that they will be responsible for the device's safety, effectiveness and quality.

For all device classes including Class I, an HC private label device must be identical in every respect to a device made by the original manufacturer and licensed (i.e. device licensed for II, III and IV, or establishment licensed for I) by HC for marketing in Canada, except that the labeling instead contains the private label manufacturer's name, address and product identifier instead of the original manufacturer's. There can be no other differences, including labeling differences. If a device is unique and is made by a contract manufacturer solely for a third party, and not also marketed and licensed by the contract manufacturer, the third party is not eligible for the Private Label rules and instead is regulated as the original manufacturer.

HC private label manufacturers are required to have their own systems for complaint handling, problem reporting and recalls. In the case of an HC inspection, those would be the inspection topics.

 

[Mark Meer]

Thanks MIREGMGR. You are truly an "Appreciated Information Resource"!

So just to sum up this thread:

For Health Canada a private label manufacturer:

• Must have a device licence (for Class II, II or IV) or MDEL (for Class I)
• Can use the ISO13485 certificate of the original manufacturer to comply with SOR-98-282 32.2(f)
• Must have systems for complaint handling, problem reporting and recalls, but otherwise do not need a formalized quality system.