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Bernard Murphy

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Spanish Medtech Gets Ad Approval Stamp, Looks To Rekindle Purchasing

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.

Spain Policy

Brazilian Medtech Welcomes Parametric Release Sterilization Regime

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.

Brazil Medical Device

Brazil Unifies Registration Coding For Imported And Home-Produced IVDs

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.

Brazil Regulation

Spain Tightens The Screw On Medtech Supply Costs

Spain has introduced a new health-care goods and services purchasing catalog, with the primary aim of further tightening spending.

Spain Policy

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.

Brazil Medical Device
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