GMP (Good Manufacturing Practices) for IVD Manufacturer

D

davidespada - 2011

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
 

sagai

Quite Involved in Discussions
Correct me if I am wrong.
Does CGMP conformance self declared in case you market your device as a diagnostic medical device just right when you first submit your 510k for US clearance as a consiquence of 61FR52602 ?

br
Sz.
 

Marc

Fully vaccinated are you?
Leader
Quick 'Bump' - Can any of the Medical Device folks here add to this? My Thanks in advance!
 
D

davidespada - 2011

So, Sagai,
do you think that autodeclaration would be ok? Please mind that currently we don't sell in US.
 

sagai

Quite Involved in Discussions
I think declaration of conformity without serious reason can raise unpredictable consequences and amount of future corrective duties.
As far as I concern all declaration of conformance to a standards are only part of your mandatory regulatory submission/reporting (CE/510k/etc.) and very suggested to be narrowed its scope as much as the corresponding rules allow it (or even further).
Where is this requirement for GMP "certificate" coming (customer/notified bodies/etc.) ?
May be the clarification of the intent of the need for "certificate" can be useful.

br
Sz.
 
D

davidespada - 2011

Huhu!
Well, usually the request come from Customers who needs to register the Devices (IVD) in their Countries. Our active market is middle and far east.
 

sagai

Quite Involved in Discussions
I should have place a bet on your answer :)

I would suggest to talk to them, why is is so important.
My assumption is that the type use of your device (just like in other countries) in those countries determines your customer's money refunds or purchase support from their local government.
In this case the local regulation shall be reviewed in order to allow them to have it, not voluntarily bind your company to the most strictly regulation (cGMP) on planet Earth. :)

As a worst case, you may find the local regulation simple declare cGMP, which means in my view (correct anyone if I am wrong) they shall purchase these diagnostic devices from the US market to fulfill it.
And this would close the circle.

br
Sz.
 
D

davidespada - 2011

Well,
I didn't know that. We have always provided an autodeclaration apostillated from the government (Italy is sooo strange!) and they were happy with that. But I always guessed about.
Another strange think it happen in Italy is that *nobody* is issuing a "manufacturing licence", which is another type of requested document.
But the most strange Italian issue is that our MHO does not provide us with a Registration Number!
What a mess for me!
Sagai, many thanks for the info...
BR,
Davide
 

Rocke

Involved In Discussions
Hi Davide,

We have experienced similar.
Indeed some countries do not issue manufacturing licenses.
We typically use our VAT-number (tax-number) as registration number and a certificate from our Commerce and Companies Agency indicating this number in addition to our ISO certificate.

Regards
Camilla
 
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