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Brazil Simplifies Class I Approvals To Focus On Higher-Risk Products

 
• By Bernard Murphy

Brazil has passed legislation enabling class I (lowest risk) devices and diagnostics to gain market approval through a notification pathway rather than under the current review-based registration system. The move is essentially intended to help regulatory agency Anvisa refocus its efforts toward the higher-risk arena.

Brazil

Brazil's notification pathway regime, which comes into effect on May 2, 2019, is enshrined in Resolution RDC 270 of Feb. 28, 2019, through amendments to RDCs 36 and 40 of Aug. 26, 2015. These regulate, respectively, in vitro diagnostics and medical devices, across both classes I (low risk to individual patients and low risk to the public) and II (medium risk to individual patients and low risk to the public). RDC 270 affects home-produced and imported products, but does not apply to products made for exportation.

RDC 270/2019 features two main sections. The first, under the Chapter 2 heading, covers essentially the amendments to the registration...

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• By Brian Bossetta

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• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

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Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

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