Brazilian Medtech Welcomes Parametric Release Sterilization Regime

02 Jul 2019

• By Bernard Murphy

Brazil has approved a long-awaited reform of its medical device sterilization protocols, with the adoption of a parametric release regime – a move which the industry has welcomed as “putting an end to a significant barrier” to local medical technology business.

Brazil's medical technology regulatory agency, Anvisa, has enacted Regulation RDC 291, of 24 June 2019, enabling, with immediate effect, new devices sterilized using ethylene oxide to be certified as sterile under a parametric release protocol (subject to standards ABNT NBR ISO 11135:2018) or using biological markers. Parametric release essentially relies on progressive stages of sterilization instead of a series of final sterility tests.

Until now, under Ordinance (Portaria Interministerial) 482, of April 1999, which RDC 291/2019 replaces, both biological marker and sterility tests...