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Latest From Bernard Murphy
Enhancing trust in medical devices and medtech companies is the aim of a new agreement between the Spanish medtech industry and an organization specializing in helping businesses meet and maintain high legal and ethical standards.
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.
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.
Spain has introduced a new health-care goods and services purchasing catalog, with the primary aim of further tightening spending.
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.