Does MDSAP replace ISO 13485, or do both have to be maintained?

[Mark Meer]

...
First, there's no "ISO 13485 certification". What exists are certification schemes -a certification program with its own rules, ....

Can you use your MDSAP certificate to show compliance to ISO 13485? Or even the IAF, or any certification scheme based on ISO 13485?
The answer depends on what you are using it for.

For example, to het the benefits of the MDSAP program, you have to use and MDSAP certificate, they don't accept an ISO 13485 certificate from other schemes (this is generally true for most schemes, unless there's a recognition agreement between schemes).

Thanks Marcelo, this explanation helps.

I recognise that the benefits of MDSAP have to have MDSAP, but I'm more curious about the reverse: are there cases where ISO 13485 might be required but an MSDAP certificate would NOT be adequate?

(in otherwords, is there any reason to maintain the IAF scheme?)

 

[Marcelo]

Thanks Marcelo, this explanation helps.

I recognise that the benefits of MDSAP have to have MDSAP, but I'm more curious about the reverse: are there cases where ISO 13485 might be required but an MSDAP certificate would NOT be adequate?

(in otherwords, is there any reason to maintain the IAF scheme?)

Unless you can guarantee that the uses of the 13485 certificate you have right now can be complied with with me MDSAP certificate (which I doubt as it's still in the early phases of implementation), you will need the separate ISO 13485 certificate.

For example, if you are under the Brazilian INMETRO product certification scheme (which has an audit component to show conformity to some ISO 13485 requirements), instead of being audited on ISO 13485 (which is a requirement of the certification scheme), you can use a valid ISO 13485 certificate (issued by an organization accredited by some accreditation body which INMETRO has a MOU with or is part of the same MLA) to show compliance instead of the audit. This is clearly defined in the produto certification scheme rules.

So in that case, a MDSAP certificate won't work. To have this option the product certification scheme rules would have to be changed.

In the future, when and if MDSAP begins to be more known and accepted, it may be the case that other uses may be available. Right now and for the foreseeable future, the only real use is the use as defined by the regulatory bodies of the MDSAP program.

 

[Ronen E]

So much of a "single audit" program...

 

[Mark Meer]

Unless you can guarantee that the uses of the 13485 certificate you have right now can be complied with with me MDSAP certificate (which I doubt as it's still in the early phases of implementation), you will need the separate ISO 13485 certificate.

For example, if you are under the Brazilian INMETRO product certification scheme (which has an audit component to show conformity to some ISO 13485 requirements), instead of being audited on ISO 13485 (which is a requirement of the certification scheme), you can use a valid ISO 13485 certificate...

Hmmm...it doesn't seem like there's a great a case for getting on the program (except the Canadian mandatory adoption). No wonder the sign-up participations for the pilot have been so unpopular!

One issue that comes to mind is the distributors we deal with having a requirement for ISO 13485 baked into their supplier evaluations. If issued MDSAP certificates read "ISO 13485:2016 under MDSAP", then I don't see a problem. ...but if issued certificate just say MDSAP (without any reference to ISO 13485), this might be a headache in terms of explaining to customers the difference...

 

[Marcelo]

One issue that comes to mind is the distributors we deal with having a requirement for ISO 13485 baked into their supplier evaluations. If issued MDSAP certificates read "ISO 13485:2016 under MDSAP", then I don't see a problem. ...but if issued certificate just say MDSAP (without any reference to ISO 13485), this might be a headache in terms of explaining to customers the difference...

It will have the 13485 mention because ISO 13485 is the basis - see requirements for the certificate here: (broken link removed)

 

[Marcelo]

So much of a "single audit" program...

It's a "single audit" for acceptance inside the program (even if the level of acceptance is different between regulators). They've never mentioned that it would be a single audit acceptance for every and all cases.

 

[Marcelo]

Hmmm...it doesn't seem like there's a great a case for getting on the program (except the Canadian mandatory adoption). No wonder the sign-up participations for the pilot have been so unpopular!

This is the main problem I see with the program - there's never been a business case for it, because the problem was created to solve the regulator's problems (for example, lack of resources), not manufacturers/importers/etc problems.

 

[mihzago]

So INMETRO would not recognize MDSAP audit even though ANVISA, which is one of the member states and in effect an accreditation body, supports the MDSAP program audits to show compliance with BGMP?
Is this right?

Besides, how many certification schemes for ISO 13485 are there? My BSI cert does not mention any, so I would venture to say there's only one (IAF?).

I didn't think, and I still don't think you can maintain two certificates, but I'll ask my CB.

 

[ganglai]

MDSAP does not replace ISO 13485.
It replaces the CMDCAS program for Canada and adds the regulatory requirements for USA, Australia, Japan, and Brazil.
...

Is MDSAP required for all classes of medical devices?

I recall CMDCAS is only required for class II and above medical devices (please correct me if I am wrong). If MDSAP replaces CMDCAS, does it mean class I medical device manufacturer will require MDSAP as well? Thank you!

 

[Ronen E]

They've never mentioned that it would be a single audit acceptance for every and all cases.

Of course. The thing is, when the work item was initiated at IMDRF (and even before), I think the driving force was more efficiency, and hopefully one day having one audit with wide acceptance. Doesn't seem wide at all, right now and in the foreseeable future.