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
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