BRA/855
WTO/TBT
BR Brasilien
  • 11 - Medizintechnik
2019-03-02
2019-01-04

Medical devices

Draft Resolution 584, 21 December 2018, published by Brazilian Official Gazette (5 page(s), in Portuguese)

This draft resolution proposes the medical devices classification as single use or reusable, among other measures.

This resolution has the objective of establishing the medical device classification as single use or reusable for regularization with Anvisa, as well as information to be considered on the instructions for use and the label of such devices.

This resolution does not apply to in vitro diagnostic products.

This resolution applies to manufacturers and importers of medical devices, registration holders, as well as health services. It also applies to the processing companies of health products regarding planning and execution of processing activities of medical devices.

The registry holder is responsible for evaluating and establishing the classification of the device in one of the options presented in this document, from the project of the medical device, based on technical-scientific evidence, risk assessment and validation of project and applicable process.

Manufacturers shall define, establish and document the technical-scientific rationale that corroborates the proposed classification for the medical device.

The Resolution of Collegiate Board of Directors - RDC No. 156 of 2006 and Specific Resolution - RE No. 2605, of 2006 is hereby revoked. This Resolution shall enter into force 60 days from the date of its publication.