Sep 30, 2015

Brazilian medical device market regulator ANVISA has published a new list of technical standards to which some electrical medical devices and IVDs must comply in order to obtain INMETRO certification in the country.

The new ANVISA normative instruction, IN 04/2015, replaces IN 11/2014, and updates compliance timeframes for various IEC 60601 standards. Two major updates are included in the new instruction.

First, ANVISA has removed INMETRO certification requirements for IVD products; specifically, IVDs have been exempted from complying with IEC 61010-2-101:2002 (safety requirements for electrical equipment for measurement, control and laboratory use) and with ISO 15197:2013 (requirements for blood glucose monitoring systems designed for self-testing).

Second, the new instruction has pushed back compliance dates for some standards that Brazilian testing labs do not yet have the capacity to monitor. For example, although IEC 60601 3rd Edition series testing is now mandatory for INMETRO certification, testing labs in Brazil are not yet able to test according to some 3rd edition standards. In the meantime, manufacturers may submit test reports showing compliance with earlier versions of the 60601 standard in order to obtain their INMETRO certifications.





  • Stewart Eisenhart