Brazil Unifies Registration Coding For Imported And Home-Produced IVDs
Executive Summary
In vitro diagnostic (IVD) product registrations in Brazil are now subject to the same procedures and codes, irrespective of whether they are imported or manufactured in the country.
You may also be interested in...
Brazil Simplifies Class I Approvals To Focus On Higher-Risk Products
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.
Italy Boosts Per Capita Spend On Medtech, But Key Questions Hang Over Needs
The outlook for sustained COVID-19 recovery in Italy has cheered the medtech industry, but the private sector spend has contracted, and Italy’s imaging equipment is aging rapidly.
Brazilian Medtechs Leave Gloomy 2021 Far Behind As Exports Hit New High
Brazil's ABIMO medtech industry association reports newly-buoyant levels of export activity, as normal business routines crystalize further in the post-COVID phase. Meanwhile, member companies of the Brazil Health Devices initiative are outperforming industry averages.