Brazil - RDC 183 - Finished device - Definition Question

Edugar

Involved In Discussions
#1
Dear all,

One doubt related with the RDC no. 183 dated 17th October 2017. The definition of “finished device”, in "section III Definitions", says: "Finished device: the product, being one, a family, a system, or a set of products, which is ready for use or functionally complete, whether it is packed, labeled, or sterilized, or not"

What is understood by “functionally complete” in a sterile device?
• The sterilized and released device
• The sterilized device pending of the final release
• The packed device pending of the sterilization and final release
• Other?

As released device I understand that the device has the final approval and signature of the responsible person (usually the QA Manager).

Thanks!!
 
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Edugar

Involved In Discussions
#2
Dear all,

my previous message was related with the manufacturing sites that are subject to Good Manufacturing Practices Certification for the purposes of authorization, authorization renewal, or change (inclusion or alteration) of medical devices manufacturer at Anvisa.

The article 6 of the RDC no. 183 says:
I – Manufacturing site that makes a finished device in its name or for another company;
II – Manufacturing site that is responsible for releasing the finished device, related to at least one production stage, except for designing, distribution, sterilization, packing, and labeling stages; and
III – Manufacturing site of Software as a Medical Device – SaMD.
Sole paragraph. Anvisa shall not issue a Good Manufacturing Practices Certificate to manufacturing sites not provided for in this article.

What is understood for I? The manufacturer that appears in the label? The manufacturer that acts as OEM? Other cases?
Would a subcontracted company that carries out an assembling and packaging of a product, but not the final product release, falls in II?

Thanks!
 
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