Re: Medical device registration process in Brazil - Anvisa
The Brazilian classification rules as the same as the medical device diretive classification rules (not the revised ones). RDC 185, which is the general medical device legislation, is almost a copy of the MDD.
This is the basic problem of the brazilian regulation...it´s based on the MDD, but have a GMP derived from the FDA.
The discussion on Anvisa accepting ISO 13485 certification is an old one. In general, Anvisa´s refusal on accepting ISO 13485 is dus to the fact that ISo 13485 is "less stringent" than a GMP. This is true, but they miss the point that both are ways to demonstrate the "quality system" aspect of medical device regulations.
You´re right, recently there´s been major modifications on brazilian the medical device requirements. RDC 25 (whose implementation period will be until May 2010) requires a strictly enforced B-GMP inspection scheme, even to foreign manufacturers. It applies to product of Class III and IV (IIb and III of MDD), II, III and IIIa IVDs, and the exceptions of RDC 24 (see below, these products are the ones to which the future RDC 26 will apply).
RDC 24 is for Class I and II devices...devices under RDC 24 do not require a registration anymore..they requires a "cadastre" (but there´s a list of exceptions, for example, medical electrical equipment). Equipment under RDC 24 does not need a B-GMP certificate, but they still need to comply to the B-GMP
RDC 26 (which is in public consultation right now) will apply to the exception list of RDC 24 and will also require a strictly enforced B-GMP inspection scheme, even to foreign manufacturers. These devices will still need registration.
Abimed (which is the brazilian medical devices importer and distributor association) has been for a time trying to convince Anvisa on the acceptance of foreign inspections of ISO 13485 (this would be in place of the GMP) to no avail.
The option of using an INMETRO_IAF scheme is a new possibility we are discussing, but it applies only to the certification of medical electrical equipment, not to other medical devices (incidentally, i´m a member of Abimed and i usually gives them technical help on the medical electrical equipment certification process, of which i have a lot of experience).