Central & South America - Aug/Sep 2018

September 4, 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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