Medical equipment (ICS code(s): 11.040)

Draft resolution 1200, 01 September 2023; (6 page(s), in Portuguese)

This Draft Resolution contains provisions on the establishment of an optimized procedure for the analysis and decision of requests for registration of medical devices, through the use of analyzes carried out by an Equivalent Foreign Regulatory Authority.

For the purposes of adopting the optimized analysis procedure, the following AREE andrespective proof of registration or authorization:

I - Australia: Australia Therapeutic Goods Administration (TGA) – Australian Register of TherapeuticGoods (ARTG);

II - Canada: Health Canada (HC) – Medical Device License;

III - Japan: Japan Ministry of Health, Labor and Welfare (MHLW) – Pre-market approval (Shonin) fromMHLW; It is

IV - United States of America (USA): US Food and Drug Administration (US FDA) – 510KClearance or Premarket Approval (PMA).