FYI....
Recently ANVISA, the Brazilian medical devices regulatory body, published Normative Instruction 13/2009, which aims to facilitate the medical devices registration process by requiring that less documents be sent to the agency. In the other hand, the document also defines the documentation which needs to be compiled and withheld, and which Anvisa request if needed (and the manufacturer/distributor/etc will have 30 days to show them).
One of the practical changes is that the technical file won´t be sent, unless the device is a new technology or have a new indication for use.
Also, the contents of the technical file are better defined, and they include the risk management file based on ABNT NBR ISO 14971 (the Brazilian versions of ISO 14971).
In practice, as the risk management files details the process implemented based on the whole standard, what it means is that ABNT NBR ISO 14971 is now mandatory in Brazil.
Although i´m always worried whena standard becomes mandatory, i think that´s in this case it will be beneficial...but let´s see what happens.
Recently ANVISA, the Brazilian medical devices regulatory body, published Normative Instruction 13/2009, which aims to facilitate the medical devices registration process by requiring that less documents be sent to the agency. In the other hand, the document also defines the documentation which needs to be compiled and withheld, and which Anvisa request if needed (and the manufacturer/distributor/etc will have 30 days to show them).
One of the practical changes is that the technical file won´t be sent, unless the device is a new technology or have a new indication for use.
Also, the contents of the technical file are better defined, and they include the risk management file based on ABNT NBR ISO 14971 (the Brazilian versions of ISO 14971).
In practice, as the risk management files details the process implemented based on the whole standard, what it means is that ABNT NBR ISO 14971 is now mandatory in Brazil.
Although i´m always worried whena standard becomes mandatory, i think that´s in this case it will be beneficial...but let´s see what happens.