Attestation of QA certificate from foreign (EU) Notified Body

C

catechol

#1
Hi everyone!

Time to break the ice with you all, with (I hope) a simple question regarding registration abroad -- 'cause I'm clearly missing something and apparently my Google skills are sub-par, haha. Anyone willing to help out a fellow MD developer?

I'm new to RA and currently registering our Class IIa non-invasive OTC medical devices in a few Middle Eastern countries and elsewhere. From Pakistan, I'm asked for a legalized, attested copy of one of our Quality Assurance (production) certificates on which the product is listed. This happened to have been awarded to us by a German NB, and hence it is in German. We are a Dutch company. I've seen fellow manufacturers providing international QA certificates when necessary, which had been legalized by small Dutch notary offices. However, when I approach these offices, they tell me the signature must be a Dutch one.

What it comes down to: obviously I don't want to take the German certificate through international law instances across borders. Is there a method that circumvents having to attest a hardcopy of the certificate itself? Or perhaps an institution that can accredit European Quality certificates within the national judiciary system?

I look forward to your responses!
 
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shimonv

Trusted Information Resource
#2
Hi Catechol,
Odd.. I haven't see a notified body certification (QMS or CE certificate) that is not in English.
Have you tried contacting your NB and ordering few original copies in English? If its an original document you might not need to get it notarized.

Shimon
 
C

catechol

#3
Hi Catechol,
Odd.. I haven't see a notified body certification (QMS or CE certificate) that is not in English.
Have you tried contacting your NB and ordering few original copies in English? If its an original document you might not need to get it notarized.

Shimon
Hi Shimon, thanks for replying, much appreciated!

Incidentally, the route you suggested was similar to the route I followed in the mean time. For this particular registration, the English document in question required no attestation, fortunately.

Nevertheless, I do wonder what an efficient route would be, in case foreign attestation (or even just notarization) of the EU certificate (DE->NL) had been necessary... or perhaps such cases never occur, for this very reason?

A general consideration I have with these processes is that I want to avoid hassling our NB too much for such matters. Ordering a bunch of original copies at once seems strategic and efficient, for sure, but other requests will always come, and I'd like to preserve a good relationship and not pressing/awaiting the NB's busy schedule.

Any industry tips or lessons in skipping NB-dependent steps are welcome!

Thank you :)
 

shimonv

Trusted Information Resource
#4
You are very kind toward your notified body... I'll give you that. But don't worry, they get paid for these services.
Keeping a bunch of original certificates in English is the best thing you can do. As you move forward other issues will arise and you will deal with them as they come.

Shimon
 

Marcelo

Inactive Registered Visitor
#5
Notified bodies do not issue Quality Assurance certificates. They only issue certificates related to the CE Marking routes they are designated too. For a quality assurance certificate, you need to contract a certification body (which may also act as a NB), but they will totally follow different rules.
 
C

catechol

#6
Sorry Marcelo, you're right, I've been using 'notified body' interchangeably with 'certification body', my bad.

Thanks for keeping an eye on correctness for everyone here. :)
 
C

catechol

#7
You are very kind toward your notified body... I'll give you that. But don't worry, they get paid for these services.
Keeping a bunch of original certificates in English is the best thing you can do. As you move forward other issues will arise and you will deal with them as they come.

Shimon
Check, doing that from here on out. Thanks for your input!
 
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