ANVISA RDC 16 - purchasing records

LFZR88

Involved In Discussions
#1
Hi Marcello,
specifically for ANVISA i have a question

We would like advice on the interpretation of RDC 16 part 2.5.4 and 2.5.6 please. We are the legal manufacturer of products for which we contract out processes to our approved suppliers. The processes contracted out vary from product to product.

We have been informed that all raw materials used in the manufacture of our products for Brazil need to be physically purchased by us (PO placed by us), and not by a subcontractor. Is this the case? We are experiencing difficulty in purchasing the raw materials directly since our suppliers do not wish to share the commercial information/ prices with us.
Please can you advise on this?
 
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Marcelo

Inactive Registered Visitor
#2
Re: Guidance for medical device registration in Med Dev Regulations World-WIde

Hi Marcello,
specifically for ANVISA i have a question

We would like advice on the interpretation of RDC 16 part 2.5.4 and 2.5.6 please. We are the legal manufacturer of products for which we contract out processes to our approved suppliers. The processes contracted out vary from product to product.

We have been informed that all raw materials used in the manufacture of our products for Brazil need to be physically purchased by us (PO placed by us), and not by a subcontractor. Is this the case? We are experiencing difficulty in purchasing the raw materials directly since our suppliers do not wish to share the commercial information/ prices with us.
Please can you advise on this?
RDC 16 requires that you have purchasing records for are material, components, etc. that define the specification (requirements) for what you are purchasing. This is nothing different than what ISO 13485, for example, requires.
In you example, you would need to clearly define the requirements of what your get from your subcontractor.

For example, if you buy a PCI from a subcontractor, you don't need to buy yourself the components, your subcontractor can buy them. But you need to have purchasing records that clearly describe what you will buy from the subcontractor (and it might include requirements for components, if that's the case).
 
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LFZR88

Involved In Discussions
#3
Re: Guidance for medical device registration in Med Dev Regulations World-WIde

Hi Marcelo,
Sorry for using the wrong thread, thanks for the reply.
 
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