"Quality Management System" Certificate vs. "Quality" Certificate?

SSchoepel

Involved In Discussions
Hi, I'm looking into registering our medical device in some countries in the Middle East and Asia. I've come across requirements that say we need to submit the Quality Management System certificate and the Quality Certificate.

I found this specifically for Bahrain, though others list both but without the parentheses:
Quality managements system certificates (GMP, ISO, FSC, Full quality assurance )
Quality Certificates (FDA, CE Mark, etc)

Would I be able to submit the FDA clearance certificate for both? We will be going for CE marking later this year. Could I use the CE Mark certificate for both?

What is the difference between them as it seems they are requiring an additional certificate that isn't necessary even for the EU.

Thank you
 

Ronen E

Problem Solver
Moderator
Hi, I'm looking into registering our medical device in some countries in the Middle East and Asia. I've come across requirements that say we need to submit the Quality Management System certificate and the Quality Certificate.

I found this specifically for Bahrain, though others list both but without the parentheses:
Quality managements system certificates (GMP, ISO, FSC, Full quality assurance )
Quality Certificates (FDA, CE Mark, etc)

Would I be able to submit the FDA clearance certificate for both? We will be going for CE marking later this year. Could I use the CE Mark certificate for both?

What is the difference between them as it seems they are requiring an additional certificate that isn't necessary even for the EU.

Thank you

Quality management system certificate is quite clear.
What they mean by "Qualiy certificate" is a little more vague, but it seems that they're looking for some esteemed regulatory domain clearance evidence.

I'm not sure what you mean by "FDA clearance certificate". If you refer to the SE letter (510k clearance) it's not exactly a QMS clearance certificate because a 510k review doesn't involve a QMS inspection / audit. If you refer to your registration / listing documents, they're almost worthless as quality evidence (certainly as QMS certificates). Did you go though a PMA? Did you have an FDA inspection on site?

The EC certificate might be a little more useful, because if your device if classified higher than class 1 the existence of an EC certificate from a NB would indicate that your QMS was audited and approved.
 

SSchoepel

Involved In Discussions
Thanks, that's what I thought. We did not do a PMA as we are not class lll.

I'm trying to make a brief chart of what we need before we can go for each country's registration/certification and this helps. Most non-EU countries seem to need the CE mark evidence if they do not have legislation of their own that is equally as stringent.
 
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