Anvisa Manufacturer Audit - Product produced at two different Sites

C

chloep17

#1
Could someone with experience please advise.

We are the legal manufacturer of a medical device, however the product is actually produced at two different sites. Would ANVISA want to audit both of the production sites and would this effect the overall ANVISA cost?

Any information would be greatly appreciated.
:thanx:
 
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Marcelo

Inactive Registered Visitor
#2
Anvisa is worried about the production process, and is also worried with the the most important/relevant/dangerous part of the process. When the Brazilian registration holder apply for the certification, you will need to clearly define what is done where. And then Anvisa will decide where it will perform inspection. It can be one plant, both, or even both AND your own, if Anvisa thinks that it need to be.

The cost is not altered. You pay the usual US 22.000 and then Anvisa will use this money in the inspection, even if they decide to inspect more than one plant.
 
H

HammyH

#4
Hi Marcelo,

In your response above, you say "The cost is not altered. You pay the usual US$22.000 and then Anvisa will use this money in the inspection, even if they decide to inspect more than one plant."

This is interesting, we too are the legal manufacturer of medical devices (we have no production at our European head office facility and have been advised that no ANVISA inspection is required here). The product is actually produced at two different sites in China (two separate companies). We have submitted two inspection requests to ANVISA for separate audits at each of the production sites. We have paid US$22.000 for the inspection of one company and US$22.000 for the inspection of the other.

Is this correct because production is taking place at two separate companies, or should ANVISA visit both companies as part of one inspection costing US$22.000?

What about the situation where production takes place within one company, but at two different locations. For example, this happens at one of the companies in China that is making the medical devices. The first part of the production process (raw material receipt, QC, first part of production) is taking place in one building. The part-finished devices are then moved to a different building (with a different address, about 2 kilometers away, but still in the same city) where the production process is completed (finished device assembly and packing). The buildings share the same QMS. In this case, do we need to have two separate ANVISA inspections (and pay US$22.000 x2) or could both buildings be inspected during one inspection visit (and we only pay US$22.000 x1)?

Thanks for any guidance you can provide,
HammyH
 
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