Draft resolution 1200, 01 September 2023

Protection of human health or safety (TBT)

Medical equipment (ICS code(s): 11.040)

Link to ePing

11.040 - Medical equipment

Human health

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 and respective proof of registration or authorization:>I - Australia: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);>II - Canada: Health Canada (HC) – Medical Device License; III - Japan: Japan Ministry of Health, Labor and Welfare (MHLW) – Pre-market approval (Shonin) from MHLW; It is>IV - United States of America (USA): US Food and Drug Administration (US FDA) – 510K Clearance or Premarket Approval (PMA).

1:File here 2:File here 4:File here 6:File here

EN:File here

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