Changes Afoot for Medical Device Manufacturers in Argentina, Brazil, Colombia and Cuba

The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers. The regulatory bodies ANMAT (Argentina), ANVISA (Brazil), INVIMA (Colombia) and CECMED (Cuba) have recently signed an agreement as a result of an initiative which was passed during the Pan-American Health Organisation (PAHO/OPS) September/October 2010 summit.

The details of the mutual agreement are to be defined during 2012 and it is hoped that the agreement will be operative from 2013. The four regulatory bodies will work independently to begin with to certify manufacturers as compliant with mutually recognised good manufacturing practice (GMP) standards. This model will then adapt to allow for joint inspections to the GMP standards. Down the track it is planned that other activities (including product recall) will be completed on a mutual basis.

The mutual agreement will mean reduced regulatory burden for medical device manufacturers in these regions, and may eventually broaden to bring benefit to overseas manufacturers also.  As with many other regions worldwide, a mutually governed approach to medical devices is developing.

For assistance obtaining regulatory certification outside of Australia, please contact KD&A.