Central & South America - Aug/Sep 2018

Brazil: Plans to replace cadastro registration with notification system for Class I devices
Brazil: Barcodes to be required for coronary stents and hip and knee implants
Brazil: Compliance with ISO 15197: 2013 is mandatory for self-testing blood glucose monitoring systems and their consumables
Brazil: Import checks will focus on products of greater risk and companies with a poor track record
Brazil: ANVISA plans to propose the addition of ‘systems’ to IN 03/2015
Mexico: Guidance published on digital advertising of medical devices

Click here for the full article on Global Regulatory Press.

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