Medical devices in Brazil are classified in four classes based on the risk they pose to the human body. Risk Level. Classifiion. Low Risk. Class I ; Medium Risk. Class II: High Risk . Class III : Very High Risk. Class IV: Grouping Rules. Material: 14. Noninvasive medical devices: 58. Invasive medical devices: 912. Active medical devices: 1318 . Special rules: Medical .
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Get Price· Send the Dossier, RDC 185/2001, and other legal documents to the BRH in case a future onsite inspection is to be done by ANVISA. (Only Class II IVD devices must have their Dossiers submitted to ANVISA.) All files must be submitted in Brazilian Portuguese. Pay the appliion fee, for Class I devises the BRH will send an abbreviated appliion ...
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