HS Code(s): 3002300, 3822 (In vitro diagnosis products)

Draft resolution number 734, 22 October 2019. Number of pages: 20; Language(s): Portuguese

This draft resolution proposes the updating of the Resolution – RDC number 36, August 26^th, 2015, which establishes the risk classification, control scheme of notification, registration, market authorization and technical requirements for labelling and usage instructions of medical devices for in vitro diagnosis.