Hello Joy,
In Brazil there are different IVDs approval pathways. One is the "cadastro" which is a kind of product notification and it is applied to Class I and II. The other one is the "registro" which is applied to Class III and IV.
I have roughly translated the part of ANVISA's Manual for Regularization of IVDs where the classification is described.
I will be happy to go through the necessary information with you. For that I suggest that we schedule a call and I can explain some preliminary information and search for your product classification. After that, you can decide if we can be of further assistance to your company with respect to advice and/or preparation of your product submission for Brazil.
"- Class I - Low risk to the individual and low risk for the public health.- Class II - Medium risk to the individual and/or low risk for the public health.- Class III - High risk to the individual and/or medium risk for the public health.- Class IV - High risk to the individual and high risk for the public health.The framework for in vitro diagnostic products is guided by a set of rules aimed at classifying products taking into account the following criteria:
I - the indication of use declared by the manufacturer.
II - the technical, scientific or medical knowledge of the user;
III - the importance of the information provided to the diagnosis;
IV - the relevance and impact of the result for the individual and for public health; and
V - the epidemiological relevance."
ANVISA has on its website a list of technical names for IVDs (in Portuguese) and it is possible to perform a search to identify the appropriated product category. The link is http://www.anvisa.gov.br/datavisa/NomesTecnicosGGTPS/Consulta_inVitro.asp?ok=1
As I mentioned above, I will be pleased to help you with that. I will need to have some details about your product.
Kindly let me know..
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Marcela Saad MSc, PharmD, RAC Global, FRAPS
President & Senior Consultant
MarcM Consulting Canada
+1 519 579 0821
Kitchener ON
Canada
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Original Message:
Sent: 05-Apr-2017 10:46
From: Joy Pelfrey
Subject: Brazil IVD Classification
Hello All,
Does anyone have an English document that describes how to classify IVDs in Brazil? Do they strictly follow GHTF classification system?
Thanks!
Joy
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Joy Pelfrey
Director of RA/QA
IMMY
Norman OK
United States
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