Dear Jim,
I am assuming you are talking about Medical Devices Contracted manufacturers.
ANVISA requires GMP Inspection/Certification for devices class III and IV (class I and II devices are exempt of certification).
Regaring legal manufacturers and contracted manufacturers, the table below shows the need of GMP Certification. As you can see, it is only necessary to request GMP inspection in the cases the contracted manufacturer carries, at least, the final stage and/or release of the product.
| Company / Activities | Necessary ANVISA GMP Inspection? |
| I |
MANUFACTURER performing all the stages of production. (design, production / assembly, quality control and distribution)
| YES |
| II |
MANUFACTURER (LEGAL) - that specifies the design and production requirements, making at least one stage of production (as well as design and distribution) and subcontract (outsource) the others.
| YES |
| III |
CONTRACTED MANUFACTURER - which holds 100% of production under specification of another company (MANUFACTURER LEGAL), with or without commercial distribution.
| YES |
| IV |
CONTRACTED MANUFACTURER - which performs the final stage production of the product
| YES |
| V | CONTRACTED MANUFACTURER - carrying out intermediate stages of production. |
NO
|
| VI |
MANUFACTURER (LEGAL) - which does not perform productive stages.
| NO |
Let me know if you have any other question,
Regards
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ANDRE JOCHEN RAC
SAO PAULO
Brazil
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------------------------------------------- Original Message:
Sent: 09-29-2014 10:21
From: Jim Banic
Subject: Brazil: Subocontractors to be Anvisa GMP Certified
During a registration, we were informed by our distributor in Brazil our signifcant subcontractors must be Anvisa GMP certified. This would be Level IV, Contracted Manufacturer.
We reached out to our subcontractors and none had heard of this. Most of our subcontractors have many device companies as customers besides us.
Is anyone else experiencing this in their Brazilian registrations? Is so, how are you addressing this requirement?
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Jim Banic
Regulatory Affairs Specialist
Exactech, Inc
Gainesville FL
United States
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