Do I need MDSAP?

[dr1vn]

So, say I have a SAMD app that we market in the US and Canada. I understand we need ISO 13485 under the MDSAP for Canada. But, the US is optional. Will my registrar allow this? i.e. Can we sell to both countries, but have the registrar audit us with only Canadian regulations? I get that this opens us up for audits by the FDA, but if we are located in Canada, the audit cycle is only once every few years and an FDA inspection of a SAMD company is not that much of a burden. It may be worth the cost savings of having our registrar not include the US in their audit plan... if that is allowed.

 

[I_Moy]

MDSAP covers requirements for USA, Canada, Brazil, Japan and Australia. You can have your auditing body exclude any of those requirements and limit your audit scope to some of the above (e.g. I would include USA and Canada only if you don't plan to sell in the other jurisdictions which will decrease your audit scope and you likely havent implemeted all of those countries requirements right?).
You could also exclude USA and have the MDSAP audit limited to ISO 13485 and CMDR (Canadian Medical Devices Regulation) but I don't see there being much reduction in the audit scope as FDA QSR aligns pretty tightly to ISO13485 and CMDR.

 

[DannyK]

So, say I have a SAMD app that we market in the US and Canada. I understand we need ISO 13485 under the MDSAP for Canada. But, the US is optional. Will my registrar allow this? i.e. Can we sell to both countries, but have the registrar audit us with only Canadian regulations? I get that this opens us up for audits by the FDA, but if we are located in Canada, the audit cycle is only once every few years and an FDA inspection of a SAMD company is not that much of a burden. It may be worth the cost savings of having our registrar not include the US in their audit plan... if that is allowed.

Your application to the Auditing Organization will ask you where you are distributing your medical device. You cannot exclude USA from MDSAP if you sell in USA and Canada. USA is not optional, it must be included. The auditing organization will audit you for both USA and Canadian requirements. I have some clients in Canada that tried to exclude USA from their MDSAP but were audited to it anyway. The auditor looked up the establishment registration with the FDA and found that the company was listed.
I hope this helps.
Danny

 

[dr1vn]

Thanks I-Moy and DannyK. I've had MDSAP audits before and you're right that the added auditing burden to us for both FDA and Canada is not that great as the two systems are aligned. Was just wondering if there would be some time savings and cost savings if the FDA was excluded from the scope. Especially, considering as a manufacturer without a production floor to audit, there's not a lot to see for a potential FDA inspection so I figured it would not be much of a burden to have both MDSAP (Canada only) audits and biennial FDA inspections. But seeing as the AO would not accept a FDA exclusion then looks like we've got no choice!

 

[EmiliaBedelia]

I would MUCH rather go through an MDSAP audit than an FDA inspection. At least in my experience, MDSAP tends to be a much less onerous audit and very "check the box" just because of the volume of things that they need to get through. Even with only 2 regions there are just a lot of little bits and pieces, and in reality that means that auditors often don't have enough time to go in depth. This is only based on my experiences, so take that with as much salt as you need, but I would be much more concerned about FDA than MDSAP.

If your auditors are already there for Canada, and if you are already internally prepped for it, I don't think the time/cost savings are significant enough to make a difference if you exclude the US, and you then have to deal with staffing and prepping for another separate audit.

 

[mihzago]

It's been a few weeks since this question was posted and I think you've got the answer, but I wanted to stress what DannyK already said, namely that you cannot exclude a country that participates in MDSAP if you market your product in that country. So, if you're selling in the US, then US will be automatically included in the scope. This is not optional.

The extent of your operations is irrelevant to the scope of applicable countries, but may reduce your audit time because some tasks will not be applicable.