Brazil: Anvisa amends rules related to registration of medical devices

Resolution rule no. 40/2015 of the Brazilian health surveillance agency (ANVISA) has introduced significant amendments to the record of health products by eliminating the previously existing procedures. Health products are categorized into four different risk classes: class I as low risk, class II as medium risk, class III as high risk and class IV products have the highest risk. According to the older rule 2/2011, the registration was mandatory for class III and class IV products only. However, a few exceptional class I and class II devices were also eligible for the mandatory registration, but the new rule states that registration is essential for all products related to all four classes. Moreover, some products related to health cannot be considered as health products such as products used in the assessment, development, manufacturing or preparation of health products, machinery for the manufacture of pills and equipment for making prostheses.

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