What is the relationship with the CSA group?

[MDD_QNA]

What are your relationship with CSA group? If I understand our documents correct they are a test organization and they do the electrical safety testing for Canada and US markets. However, we don't submit any changes to them. All the amendments to the license has to go through Health Canada. Is my perception correct?

 

[Marc]

Re: What is the relationship with CSA group?

Are you referring to this CSA Group?

 

[MDD_QNA]

Re: What is the relationship with CSA group?

Yes, I mean CSA group!

 

[shimonv]

Hi MDD_QNA,
The CSA group is an external laboratory recognized, among others, by Health Canada. If you look at a CSA report you will find statements like the following:

"Changes/Updates in risk management documents that affect the safety of this medical device during its lifecycle shall be communicated to the CSA Group as a condition for continued certification."

The certificate you receive from organizations such as CSA helps you when you apply to Health Canada for new licences or license amendment. Health Canada recognizes their reports as objective evidence for compliance.

Your relationship with the testing lab, much like with Health Canada, is something that lasts throughout the product life-cycle. When you make a significant change to the device you must notify CSA and follow their procedure for testing and evaluation which will result in a new report. This needs to happen before applying to the higher authority, i.e. Health Canada.

Shimon

 

[MDD_QNA]

Thanks Shimonv! It seems as though this one has slipped through our SOPs and working procedures...
So the CSA group is like an NB, correct? We want to have everything certified with one NB but for whatever reason (probably different timing for market access) 4 different NBs have been chosen.

 

[shimonv]

So the CSA group is like an NB, correct?

The CSA group is similar to NB in the sense that when you pass the certification process you are allowed to place their identifying mark on your device.

The big difference is that having the CSA mark on your product does not grant you any market access; only confirmation that your product conforms to a certain standard and that the testing was done by the CSA group.

With regards to NBs, when you pass their inspection and certification process you are allowed the place the CE mark with their identifying number beneath it, and subsequently to place your device in the EU market. That's a big deal!

We want to have everything certified with one NB but for whatever reason (probably different timing for market access) 4 different NBs have been chosen.

If you value your life - stick to one NBs. Divide and conquer approach doesn't work with these organizations.

Cheers,
Shimon

 

[MDD_QNA]

Thanks Shimon.

And what is the difference between CSA group and UL (Underwriter's Laboratories)?

 

[shimonv]

Thanks Shimon.

And what is the difference between CSA group and UL (Underwriter's Laboratories)?

In short - UL and CSA are competing accreditation bodies to support registration in North America. Price and availability is an obvious difference.
But if you are aiming to do registration in other markets such as LATAM, EU, and Asia you need to see to what extent their services will support compliance with local recognized standards.

Shimon

 

[MDD_QNA]

Does incidents need to be reported to CSA group or only HC (Health Canada)?

 

[shimonv]

You must look at the terms of your agreement with CSA to be sure.

Generally speaking, adverse events should be reported to Health Canada;
Siginificant design changes should be reported to CSA.
(CSA is a a test lab recognized by the regulator; they don't have regulatory authority by themselves.)

Shimon