GMP (Good Manufacturing Practices) for IVD Manufacturer

D

davidespada - 2011

#11
Thanks Camilla,
in fact I asked to other Italian Company and they provide the Certificate from Commerce Angency as well, but together with Free Sales Certificate.
We'll follow the same procedure.
Thanks for the advice,
BR,
Davide
 
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xcanals_tecno-med.es

Involved In Discussions
#12
Hi Davide
Here in Spain the Health Authorities AEMPS issues a "Manufacturing License" but for most of the customers the requirement is the "Free sales certificate" issued by the MOH which establishes that your products and company fulfills the country and european requirements for the IVD product.

Regards

Xavier
 

sagai

Quite Involved in Discussions
#13
Hello,
I have a lot of request for GMP certificate. Unfortunately, since we are IVD manufacturer there is no Institute who can issue a valid GMP.
As turnaround we have made an auto-declaration that the Company follows the GMP standards.
Do you have any other options?
Please considere that we are ISO 9001 and 13485 certificated.

Thanks in advance,
DavideSpada
Only for clarification regarding the GMP/cGMP related original question.
For 510k approval, you receive a letter with the following partial content from FDA:
"
...
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable,
...
"

So its from that point is a legal binding.

br.
Sz.
 
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