Revision of Brazilian GMP Regulation - RDC 16/13 (RDC 59 and Portaria 686)

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R

recruit

#2
Great news. Do you have English version or related revision summary? How does it impact foreign manufacturer?
 

Marcelo

Inactive Registered Visitor
#3
Not yet.

Foreign manufacturers (as well as national ones) must comply with the new regulation in 6 moths from it's publication.
 
K

Katalina

#6
Marcelo - This RDC No 16 of March 28, 2013 - does this apply ONLY to In Vitro medical and diagnostic devices? Or to (1) Medical Devices and (2) Diagnostic In Vitro Devices? The English translation I have is "medical and diagnostic products for in vitro use". So I am wondering if it applies to medical products which are NOT for in vitro use. Thank you!
 

Marcelo

Inactive Registered Visitor
#7
Marcelo - This RDC No 16 of March 28, 2013 - does this apply ONLY to In Vitro medical and diagnostic devices? Or to (1) Medical Devices and (2) Diagnostic In Vitro Devices? The English translation I have is "medical and diagnostic products for in vitro use". So I am wondering if it applies to medical products which are NOT for in vitro use. Thank you!
It applies to all medical devices, including IVDs.

The translation you have is wrong, "medical and diagnostic products for in vitro use" should be "medical devices and IVD medical devices".

(it?s a problem with the direct translation of what we call "Produtos para a sa?de", the direct translation in english is "health products" however, it really means medical device in Brazil).
 
S

Schorschinjo

#8
Hello,
is there any informational material that comparing the requirements of RDC 59 to RDC 16?

Thanks
 
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