Hi all,

We are required to conform to RDC 59 a medical products quality standard in Brazil.
I know very little about the requirements but they seem quite similar to other international standards.
I was wondering if anybody had performed a comparison with other standards (ISO 13485/ISO 9001:2000/21 cfr 820 etc) and identifed similarities and/or differences.

Thanks,
Paul

RDC 59 is not a standard in the way "standards" are made by standard organizations (such as ISO). Standards, such as ISO 13485, are almost always voluntary. RDC 59 is a a law, and thus, compulsory; this is in more in common with 21 cfr 820 in the USA.

And, in fact, RDC 59 is the brazilian GMP regulation. It´s "based" on the US GMP, so it has more presriptions than ISO 9001 and ISO 13485....it´s a copy of 21 cfr 820, but lacks some of the requirements of 21 cfr 820.

Sorry for the general answer, but i´ve never made an actual comparison of both. I´ve made a quick comparison from time to time because i usually use (and tell my clients to use) 21 cfr 820 as a way to understand RDC 59 better (due to the tons of additional info 21 cfr 820 has and RDC 59 does not have).

Also, there´s a little problem in the actual implementation of RDC 59, because a lot of inspectors from Anvisa have a weird interpretation of the requirements (this is a bigger problem with state or city inspectors from local visas, which sometimes perform GMP inspections but do not understand the requirements and asks for absurd implementations).

Anyway, if you´re in accordance with US GMP, there´s a good probability that you conform to RDC 59; there is, until taking this inpector crazy stuff in consideration :-)