Medical devices - Brazil Publishes Normative Instruction 29, 27 November 2018

This Normative Instruction provides the update of Annex I of Normative Instruction 4/2015 (Instrução Normativa 4, de 24 de Setembro de 2015) approving the list of technical standards to be adopted in the conformity assessment, and the updating of Annex II of IN 4/2015 (List of dates regarding the entrance into force of the standards to be adopted in the compulsory third party certification), within the scope of the Brazilian System of Conformity Assessment (SBAC). This Normative Instruction enter into force on the date of its publication.

Final Text 1 is available for download in the following languages: Portugese