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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...

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FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

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• By Natasha Barrow

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EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

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Commission Decision Launches Pediatric And Rare Disease Expert Group

 
• By Amanda Maxwell

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

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