Medical Device Registration in Brazil

Interested to know how to group and hence determine the number of submission is needed in Brazil (hence saving cost and time)?

Please see the grouping criteria below:

Art. 9 The general criteria for grouping health-care materials family are:

I – the health-care materials subject to registration must belong to the same manufacturer or manufacturing group, and have the same principle of operation, mechanism of action, indication of use, contraindication, adverse effect, precaution, restriction, warning , special care, storage condition and risk class;

II – the health-care materials subject to registration must have similar raw materials and manufacturing technology;

III – products subject to sterile and non-sterile registration cannot be grouped in the same family;

IV – products subject to registration whose manufacturer recommends single use and products subject to reprocessing cannot be grouped in the same family;

V – products subject to registration which cannot be reprocessed and products subject to reprocessing cannot be grouped in the same family;

VI – registration of a set or system in a family is not allowed.