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MDSAP - What if the company is interested in only 2/5 of those countries?
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MDSAP - What if the company is interested in only 2/5 of those countries?
MDSAP - What if the company is interested in only 2/5 of those countries?
MDSAP - What if the company is interested in only 2/5 of those countries?
MDSAP - What if the company is interested in only 2/5 of those countries?
MDSAP - What if the company is interested in only 2/5 of those countries?
MDSAP - What if the company is interested in only 2/5 of those countries?
MDSAP - What if the company is interested in only 2/5 of those countries?
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  Post Number #9  
Old 22nd November 2017, 01:52 PM
Mark Meer

 
 
Total Posts: 706
Re: MDSAP - What if the company is interested in only 2/5 of those countries?

Quote:
In Reply to Parent Post by Edward Reesor View Post

Further to Mark's comments above, the difference will be in the costs associated with auditing your company based on the breadth of your scope (how many of the MDSAP countries you market in). I was in a discussion yesterday with a company who suggested that if you sell very little to one of the MSDSAP countries, the costs associated with the extra audit may outweigh the money you make from the sale to that country.
My thinking as well. This is precisely why I believe Health Canada has made a big mistake in mandating MDSAP. There will undoubtedly be companies that arrive at this conclusion, and simply exit the Canadian market. ...either that or they simply transfer the costs to customers (Canadian Health Care system) in the form of higher prices.

We'll see how it plays out...

My prediction is that, as 2019 looms closer, Health Canada will either make some concessions, or extend the deadline.

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  Post Number #10  
Old 22nd November 2017, 01:58 PM
Edward Reesor

 
 
Total Posts: 58
Re: MDSAP - What if the company is interested in only 2/5 of those countries?

Its strange that the FDA is part of MDSAP but doesn't require it as long as they follow the FDA guidelines. Because Canada is 1/10 the market of the USA, many manufacturers will focus on the bigger market to the south and make a business decision against the sales in Canada. As stated in several previous posts, I know of three Canadian distributors who are at risk on losing product for this very reason and one manufacturer who is considering folding operations entirely.
  Post Number #11  
Old 22nd November 2017, 06:18 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: MDSAP - What if the company is interested in only 2/5 of those countries?

Quote:
In Reply to Parent Post by snoopy2017 View Post

Hi everyone,

MDSAP covers 5 jurisdictions. What if the company is interested in only 2/5 of those countries? Should we prepare the QMS to align with the regulatory requirements of countries we have no intention of marketing in? We would like to remain in the Canadian market;therefore the MDSAP is important to us. Please clarify.
Thank you. :thanx:
I've sat through an informative BSI webinar about MDSAP and this was one of the questions. The presenter replied that yes, you would be audited to all 5 jurisdiction requirements but are required to comply only with the requirements for the country(ies) you are selling in. She also added that registrars need to prove their competence by auditing all 5 regions and their report will contain all the findings (including those you are not required to comply with) and their report will go to all 5 jurisdiction regulatory bodies. The good part is that those findings which you are not required to comply with are not NCs - you do not need to initiate actions to address them (until you decide to enter the respective market).

That was clear as mud now, was it:)
  Post Number #12  
Old 22nd November 2017, 09:06 PM
Ronen E

 
 
Total Posts: 3,736
Re: MDSAP - What if the company is interested in only 2/5 of those countries?

Quote:
In Reply to Parent Post by Jane's View Post

I've sat through an informative BSI webinar about MDSAP and this was one of the questions. The presenter replied that yes, you would be audited to all 5 jurisdiction requirements but are required to comply only with the requirements for the country(ies) you are selling in. She also added that registrars need to prove their competence by auditing all 5 regions and their report will contain all the findings (including those you are not required to comply with) and their report will go to all 5 jurisdiction regulatory bodies. The good part is that those findings which you are not required to comply with are not NCs - you do not need to initiate actions to address them (until you decide to enter the respective market).

That was clear as mud now, was it
Clear as mud, it is...

Sounds like a big waste of resources to me. The up side is that it provides a compliance roadmap upfront, in case the manufacturer decides to go into a new jurisdiction. Still, more of a waste if you ask me (but no one does ).
  Post Number #13  
Old 22nd November 2017, 09:23 PM
Mark Meer

 
 
Total Posts: 706
Re: MDSAP - What if the company is interested in only 2/5 of those countries?

Quote:
In Reply to Parent Post by Jane's View Post

I've sat through an informative BSI webinar about MDSAP and this was one of the questions. The presenter replied that yes, you would be audited to all 5 jurisdiction requirements but are required to comply only with the requirements for the country(ies) you are selling in. She also added that registrars need to prove their competence by auditing all 5 regions and their report will contain all the findings (including those you are not required to comply with) and their report will go to all 5 jurisdiction regulatory bodies. The good part is that those findings which you are not required to comply with are not NCs - you do not need to initiate actions to address them (until you decide to enter the respective market).
I wonder if this is just a BSI policy? If they are going to audit and report on requirements for all 5 jurisdictions regardless of where devices are sold, then presumably there is no fee-adjustment for limiting the scope?

If so, this seems a bit unfair:
- Companies are subject to the same audit time (and cost) regardless of scope.
- Even if technically, findings in non-applicable regions won't be considered NCs, these findings are still published.

IMO, it'd be better if they made such a policy optional (for the benefit of companies who are planning to enter new regions in the future). For those that are not planning to expand to other regions, however, they should be granted the option of a limited scope (and reduced audit time/fees).
Thanks to Mark Meer for your informative Post and/or Attachment!
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