MDSAP benefit for manufacturer of low-risk devices

[Anne7]

Hi there,

This is my first post to the Cove (but I come here often to read many interesting threads), I hope it will be of interest for some of you.

My question today is about MDSAP. I work for a manufacturer of a low risk medical device (ISO13485 certified), and we are selling in all participating countries, except Japan.

As many other manufacturers, we feel obligated to enroll to this MDSAP because of the Canadian market. At first, we thought this audit will help us for the Canadian market and the USA, so we believed that we could ask our AO to only include those two countries in the scope of the audit.

We were wrong, as I already read at different places that the scope of this audit will need to include every participating countries where we market our device.

However, my question is the following one: what is the point of obtaining a MDSAP certificate for Brazil, even though we do not need a B-GMP certificate and we are not subject to a possible ANVISA inspection ? (Our device is registered through a "cadastro" in Brazil). The same question applies for Australia, where our CE + ISO 13485 certificates are sufficient.

It seems to us that including those countries in the scope will result in a longer audit, increased fee, and total waste of resources... All of this to satisfy Health Canada

Thanks in advance for any comments about this !

 

[Mark Meer]

...It seems to us that including those countries in the scope will result in a longer audit, increased fee, and total waste of resources... All of this to satisfy Health Canada...

Yup, that is the unfortunate situation at present.

I believe that the requirement to include all MDSAP countries you market to in the scope of your MDSAP is baked into the program, so I don't think exceptions can be made. I don't know for sure, but I speculate that this is related to the sharing of information between MDSAP regulatory bodies.

The MDSAP seems to be more of a long-term project so, depending on how Canada's mandate works out, the other countries might follow suit and eventually ditch their own quality system requirements and adopt MDSAP exclusively.

In the short term, however, I feel your frustration. I could be mistaken, but I think a small benefit is that you might no longer be subject to inspections from participating country regulatory bodies if you're on MDSAP.

 

[shimonv]

It is unfortunate indeed...

I think it's naive to expect that the other four members will follow the 'lead' of Canada and adopt MDSAP exclusively.
Also, it is unfortunate that most all of the AOs are European Notified Bodies.

-Shimon

 

[supadrai]

This is consistent with my take and our reasons/results are similar.


In the immortal Academy-Award-Nominated tune of the South Park Movie:

Blame Canada