MDSAP - What if the company is interested in only 2/5 of those countries?

[snoopy2017]

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.

 

[Ronen E]

As far as I understand MDSAP, it has some general QMS requirements (generally aligned with ISO 13485 and 21 CFR 820) which all applicants must meet. Beyond that, you are only obliged to meet (and are audited to) the regulatory requirements of jurisdictions in which you operate or plan to start operating before the next audit cycle.

But don’t trust me:

MDSAP Documents

Perhaps also not a bad idea to search Elsmar for “MDSAP” and see what those who already participate say.

 

[somashekar]

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.

19. What is the best way to determine what is expected of the Auditing Organizations with regard to multiple jurisdictions?
..... Medical device manufacturers will have to be audited according to the scope declared in their application for certification services. Based on the countries where the manufacturer sells (or intends to sell) or has devices registered, the AO will determine the regulatory requirements applicable to that manufacturer.
The AOs will have to refer to the Audit Model MDSAP AU P0002 and Audit Model Companion MDSAP AU G0002.1 to make that determination. The two documents incorporate or reference the regulatory requirements of each of the participating Regulatory Authorities.

50. If MDSAP becomes mandatory for one or more participating countries will manufacturers be expected to be compliant with regulations in a jurisdiction that it does not market?
..... The manufacturers are expected to be compliant only with the regulations for the jurisdictions where their products are marketed.

[Q19 and Q50 from the MDSAP FAQ which is shown above answers your question I hope]

 

[locutus]

I won't get on my soap box, but MDSAP is an "all or nothing" approach.

Meaning that if you are selling in Canada, US, and Japan, you must be audited to that scope for those three countries. If you do not sell in Brazil or Australia, then they would not be in the scope.

However, if you are selling in Canada, US, and Japan, and only want MDSAP to cover Canada, this is not allowed. All three countries where a company distributes product must be in the scope of the MDSAP audit.

They sneakily wrote the Q&A quite nice to say MDSAP only applies to where a company markets their products, but many companies are quite shocked when they want MDSAP for Canada only (which is required after 1 Jan 2019) and told that the other 4 countries where they sell product must also be included.

 

[somashekar]

I won't get on my soap box, but MDSAP is an "all or nothing" approach.

Meaning that if you are selling in Canada, US, and Japan, you must be audited to that scope for those three countries. If you do not sell in Brazil or Australia, then they would not be in the scope.

However, if you are selling in Canada, US, and Japan, and only want MDSAP to cover Canada, this is not allowed. All three countries where a company distributes product must be in the scope of the MDSAP audit.

They sneakily wrote the Q&A quite nice to say MDSAP only applies to where a company markets their products, but many companies are quite shocked when they want MDSAP for Canada only (which is required after 1 Jan 2019) and told that the other 4 countries where they sell product must also be included.

.... and its so the MDSAP .... SA = Single audit

 

[Mark Meer]

...Meaning that if you are selling in Canada, US, and Japan, you must be audited to that scope for those three countries. If you do not sell in Brazil or Australia, then they would not be in the scope.

However, if you are selling in Canada, US, and Japan, and only want MDSAP to cover Canada, this is not allowed. All three countries where a company distributes product must be in the scope of the MDSAP audit. ...

I can confirm (not on the program yet, but have spoken to several certification bodies re: quotations). They all say the same:

- The scope is only for the countries you market devices (and so cost reduced slightly the fewer countries that are included in the scope).
- BUT, you must include all countries you market in in the scope, so assuming you market to countries other than Canada, having a Canada-only scope is a no-go.

 

[SylvieS]

Look for the /MDSAPPilot/UCM430563.pdf
Questions / Answers from the MDSAP Pilot. (I am not yet allowed to post links)

number 95:
A manufacturer may exclude the requirements of a jurisdiction where the organization does not intend to supply medical devices. In other words, audit criteria under the MDSAP include at a minimum ISO 13485 and the medical device regulations that are applicable in any of the participating regulatory authority’s jurisdiction where the organization supplies medical devices.

 

[Edward Reesor]

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.

 

[Mark Meer]

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.

 

[Edward Reesor]

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.