Central & South America - Jun 2019

  • Argentina: Procedure for requesting an import authorisation for a medical product

  • Argentina: Regulatory controls established for sunglasses

  • Brazil: Class I medical devices and IVDs no longer require full registration, only notification

  • Brazil: Extended comment period on proposed ‘classification’ of medical devices as single use or reusable

  • Brazil: Reprocessing of products used in cardiac procedures continues to be permitted

  • Brazil: ANVISA amends IN 03/2015 to add IVD ‘systems’

  • Ecuador: Second revision of standard on natural rubber latex male condoms drafted

  • Honduras: Regulations to control medical devices and related establishments are drafted

  • Mexico: Mexican Official Standard on excimer laser ophthalmic surgery practices drafted

Click here for the full article on Global Regulatory Press.

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