The Medical Devices Introductory Course 2020

Legislative Key Players

Regulator: ANVISA http://portal.anvisa.gov.br/wp s/portal/anvisa

•Established 1999 under Brazilian Ministry of Health (Ministério da Saúde)

•Covers all healthcare / medical technology products (pharmaceuticals, devices, etc)

•Responsible for product registration, GMP inspection and market vigilance

The Organisation for Professionals in Regulatory Affairs

Legislative Framework

Complex Framework of Laws, Resolutions (“RDC”s) and Normative Instructions (“IN”s):

•RDC 185 / 2001 is the primary regulation concerning medical device regulation • Covers full spectrum of medical devices, excluding in-vitro diagnostics (see RDC # 206 / 2006 for IVDs) •RDC 16 / 2013 covers Brazilian GMP (BGMP) requirements for devices and IVDs • BGMP certificates required prior to registration submission adds long delays to device registrations in Brazil. Recent amendments (e.g.: RDC 15 / 2014) are reducing the impact , excludes class I and class II devices and recent Medical Device Single Audit Program (MDSAP) initiative expected to help

•RDC 56 / 2001 covers safety and efficacy requirements for devices

•IN 2 / 2011 identifies low-medium risk devices requiring registration (as opposed to notification)

The Organisation for Professionals in Regulatory Affairs