Future revision of ANVISA RDC 59 - Brazilian GMP

Marcelo Antunes

Addicted to standards
Staff member
Admin
#1
Heya folks

Mercosur has published sometime ago (but i forgot to mention it here, sorry :)) the revision of the Mercosur resolution which is the base for Anvisa´s RDC 59 - it´s


MERCOSUL/GMC/RES. N° 20/11 - REGULAMENTO TÉCNICO MERCOSUL DE BOAS PRÁTICAS DE FABRICAÇÃO DE PRODUTOS MÉDICOS E PRODUTOS PARA DIAGNÓSTICO DE USO IN VITRO (REVOGAÇÃO DAS RES. GMC Nº 04/95, 38/96, 65/96 e 131/96)

It´s melding the GMPs for general medical devices and IVDs (which were separated in Mercosur) and has revised requirements. I´m creating an analysis of changes and will probably put it here when done.

For those speaking Portuguese or Spanish (or using Google Translate), the resolution can be found in http://www.mercosur.int/innovaportal/v/3186/1/secretaria/resoluciones_2011
 

sagai

Quite Involved in Discussions
#3
I am totally nuts for MD clearance in Brazil, is it like the QSR in US for MD manufacturer?
Is there an english version?
Cheers!
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
I am totally nuts for MD clearance in Brazil, is it like the QSR in US for MD manufacturer?
Is there an english version?
Yes, the RDC 59 B-GMP (the version currently in use) is based on the FDA 21 CFR 820....however, it's a weird stuff, because it's based some 70 % in the 1996 version of 21 CFR 820, and 30 % on the 1976 version!

There's no english version :-(
 

sagai

Quite Involved in Discussions
#5
Thank you for answering, is it means it is working on the similar way, that the manufacturer should open its gates for inspections?
Is there anything in English about it?
Many thanks.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#6
Thank you for answering, is it means it is working on the similar way, that the manufacturer should open its gates for inspections?
Is there anything in English about it?
Yes, the manufacturer is required to be inspected - this is for class III and IV devices only.

I don´t think there´s anything in english about it.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#7
Sorry for disturbing, but it likely will be important for me, so than what is the way to enter into the Brazilian market with device would be Class C in 62304 and would be classified as Class II in US? I am a bit confused ...
Really, this is not a simple answer, on the contrary it might be quite complex. I will give you some simple directions, but you should really read the thread
Medical Device Registration Process in Brazil - Anvisa to try and understand how medical devices are regulated in Brazil.

Depending on what the software intended use is, it will probably fall under the registration process for medical devices in Anvisa (if it´s classes III or IV or "Medical software, not embeded in medical equipment, which process medical image, ou perform disgnosis, ou for use in surgical procedures, or in ICU, or directly influence the intended use of medical equipment with ANVISA registration").

Anvisa issued a technical bulletin some time ago NOTA TÉCNICA N° 04/2012/GQUIP/GGTPS/ANVISA regarding software.

There´s also, besides all other registration documentation, a form for software which constitutes it´s technical file.
 
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liuyy

Involved In Discussions
#8
Heya folks

Mercosur has published sometime ago (but i forgot to mention it here, sorry :)) the revision of the Mercosur resolution which is the base for Anvisa´s RDC 59 - it´s


MERCOSUL/GMC/RES. N° 20/11 - REGULAMENTO TÉCNICO MERCOSUL DE BOAS PRÁTICAS DE FABRICAÇÃO DE PRODUTOS MÉDICOS E PRODUTOS PARA DIAGNÓSTICO DE USO IN VITRO (REVOGAÇÃO DAS RES. GMC Nº 04/95, 38/96, 65/96 e 131/96)

It´s melding the GMPs for general medical devices and IVDs (which were separated in Mercosur) and has revised requirements. I´m creating an analysis of changes and will probably put it here when done.

For those speaking Portuguese or Spanish (or using Google Translate), the resolution can be found in http://www.mercosur.int/innovaportal/v/3186/1/secretaria/resoluciones_2011
Does it mean that in BRAZIL,GMP for IVDs will be MERCOSUR/GMC/RES.NO.20/11,while GMP for medical devices other than IVDs is RDC-59?Thanks.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#9
Does it mean that in BRAZIL,GMP for IVDs will be MERCOSUR/GMC/RES.NO.20/11,while GMP for medical devices other than IVDs is RDC-59?Thanks.
No, it means that right now there are separate GMP requirements for general devices (RDC 59) and IVDs (Portaria 622), and in the future there will be only one set of requirements (the Brazilian version of MERCOSUR/GMC/RES.NO.20/11).
 


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