Impact of an MDSAP certificate with all countries coverage

#1
Dear MDSAP experts

Can someone please explain to me the impact of an MDSAP certificate with all countries coverage?

I can identify the following 3 scenarios under the assumption that I have a full MDSAP certificate (all countries) obtained in the EU.

1) if I want to sell my product outside of the MDSAP countries (e.g. China), I need to also satisfy the destination requirements

2) if I want to sell my product inside of the MDSAP countries (e.g. Canada), my product fits the requirements listed for the MDSAP certification, and I satisfy those having a MDSAP certificate, I can sell in any of the MDSAP countries without restrictions

3) if I want to sell my product inside of the MDSAP countries (e.g. Canada), but my product doesn't fit the requirements listed for the MDSAP certification (e.g. electronic IFU), then I can sell my product in any of the MDSAP countries without restrictions
-- as long as I meet my local EU (MDR) requirements on eIFU OR
-- if I meet the destination requirements on eIFU (in which case the idea of an MDSAP certificate covering all participating markets without restriction is lost).


Your input is highly appreciated,
Richard
 
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shimonv

Trusted Information Resource
#2
1) if I want to sell my product outside of the MDSAP countries (e.g. China), I need to also satisfy the destination requirements
Correct. China is not a part of this harmonization initiative; there are only five member states: US, Canada, Brazil, Australia and Japan.
2) if I want to sell my product inside of the MDSAP countries (e.g. Canada), my product fits the requirements listed for the MDSAP certification, and I satisfy those having a MDSAP certificate, I can sell in any of the MDSAP countries without restrictions
No you may not. MDSAP cover the requirements for a quality system. To sell a product in each of these countries you may need to submit Technical File/s for review depending on local classifications and regulations.
3) if I want to sell my product inside of the MDSAP countries (e.g. Canada), but my product doesn't fit the requirements listed for the MDSAP certification (e.g. electronic IFU), then I can sell my product in any of the MDSAP countries without restrictions
-- as long as I meet my local EU (MDR) requirements on eIFU OR
-- if I meet the destination requirements on eIFU (in which case the idea of an MDSAP certificate covering all participating markets without restriction is lost).
I am not following you on this one. The EU is not a part of this global initiative. If your product is approved in the EU and you comply with the electronic IFU directive - then you may sell it with electronic IFU. Again, MDSAP cover the requirements for a quality management system for each of the listed member states. It's mandatory to meet these requirements. Any additional relevant regulatory requirement like eIFU needs to be evaluated separately per each member states requirements / regulation.

-Shimon
 
#3
Re: Impact of an MDSAP certificate

Hi Shimon


So I guess this is where I got lost. The MDSAP certificate is a system certificate.


Does that then mean that even with an MDSAP certificate the local requirements apply for a technical file audit? Thus, I have to register a product/obtain a market authorization in every single MDSAP country?


Thank you again,
Richard
 

cmeby

Involved In Discussions
#4
Your QMS will need to identify and outline the compliance of the QMS with the regulatory requirements of each country that you have listed.


We have not done ours yet, but our auditor has advised that the MDSAP Companion Document is the best guide to follow, and to ensure that the QMS clearly outlines the country specific requirements in each procedure.



Note that obtaining your MDSAP certificate mentioning the specific country does not mean that you have clearance there. You still need to follow the registration and listing processes for each country separately.
Example: Brazil states that it takes the MDSAP 'into consideration' but still may require a audit by their competent authority for that country.
 

shimonv

Trusted Information Resource
#5
Re: Impact of an MDSAP certificate

Hi Shimon


So I guess this is where I got lost. The MDSAP certificate is a system certificate.


Does that then mean that even with an MDSAP certificate the local requirements apply for a technical file audit? Thus, I have to register a product/obtain a market authorization in every single MDSAP country?


Thank you again,
Richard
Precisely.
 

Marcelo

Inactive Registered Visitor
#6
Also, each country has uses of the MDSAP certificate or report in different ways, even for the QMS requirements.

Brazil was already mentioned, but let me detail it a little more:

Brazilian regulations for medical devices divide devices into 4 risk classes, I, II, III and IV. For classes III and IV devices, one of the requirements is that a GMP certificate is obtained. Normally, this is obtained after an inspection from ANVISA.

Another way is: ANVISA recognizes several MDSAP AOs. If you have an MDSAP audit report from one of these AOs, ANVISA will consider the report for the granting of the certificate. If the test report shows compliance with ANVISA requirements, they will give the GMP certificate, instead of waiting for an ANVISA inspection.
 
#7
Wow, thank you for the enlightenment!

So to summarize, having an MDSAP certificate I still need to look into

  • how it is accepted by the destination country and
  • what the local registration/listing/market authorization requirements are that my products have to meet
in order for me to sell in that market.


Thank you for your help!
Richard
 
#8
Yes, our marketing team protested MDSAP because it did precisely nothing to speed up the time to market and was purely a theoretical (as of today) cost saver in terms of audits. We only implemented, frankly speaking, because we didn't want to pull out of Canada, which has set a January 2019 deadline for MDSAP.
 

JoshuaFroud

Involved In Discussions
#9
Re: Impact of an MDSAP certificate

Does that then mean that even with an MDSAP certificate the local requirements apply for a technical file audit? Thus, I have to register a product/obtain a market authorization in every single MDSAP country?
Richard

Yes, an MDSAP certificate is akin to any other QMS certificate, for example, ISO 13485 or 9001. MDSAP shows your Quality Management System meets the requirements of the associated countries regulation for a QMS.

The process of assessment of your specific device and associated registrations must still be conducted on a per-country basis.

Hopefully, that helps?
 
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