Medical equipment (ICS code(s): 11.040)

Draft resolution 1201, 01 September 2023; (7 page(s), in Portuguese)

This Draft Resolution contains provisions on the criteria for acceptance of toxicological evaluations of Technical Products for registration purposes resulting from decisions by the Equivalent Foreign Regulatory Authority (AREE).

For the purposes of adopting the optimized analysis procedure, the following will be considered following AREE:

I - European Food Safety Authority – European Food Safety Authority (EFSA);

II - North American Environmental Protection Agency - United States Environmental Protection Agency (EPA);

III - Australian Pesticides and Veterinary Medicines Authority -Australian Pesticides and Veterinary Medicines Authority (APVMA);

IV – Ministry of Health of Canada – Health Canada Pest Management Regulatory Agency (PMRA);

V - Ministry of Health, Labor and Welfare of Japan - Ministry of Health, Labor and Welfare of Japan (MHLW) or Ministry of Agriculture, Forestry and Fisheries of Japan - Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF).