Investor Presentaiton

Regulatory updates - Brazil Approval of new regulation on GMP - Good Manufacturing Practices inspections for medical devices - Resolution RDC 16, of March 2013. unification of requirements for both medical devices and IVD - all companies (Brazilian and foreign) had to comply with the new requirements before the 6-month “adjustment period" English version soon to be available for online consultation. ANVISA Agência Nacional de Vigilância Sanitária

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