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Brazilian Medtech Welcomes Parametric Release Sterilization Regime

 
• 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.

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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 were required to certify sterilization. This forced manufacturers to incur...

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