BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
the Chamber for the Regulation of the Medical Market (CMED). The primary regulation safeguarding com- mercially confidential and individual-related information is the “secrecy law” ( Lei do Sigilo ). Additionally, trade secrets benefit from specific legislation protection, crucial for preserving pro- prietary knowledge and fostering competitive- ness and innovation. To safeguard trade secrets effectively, compa- nies should implement practical measures: • identification and classification – recog- nise and appropriately classify information deemed as trade secrets; • access control – limit access to authorised personnel only; • contracts and agreements – incorporate con- fidentiality clauses in contracts with partners, suppliers and employees; • physical and digital security – implement measures to protect electronic documents and data physically; and • training and awareness – educate employ- ees on the significance of confidentiality and trade secret protection. 4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes In Brazil, the regulatory framework foresees routes for expediting the registration of medi- cines and medical devices. The optimisation of the registration proceedings has recently been enhanced by new rules regarding regulatory reli- ance enacted between 2022 and 2024. Addition- ally, for medical devices, the issuance of authori-
sations can be faster for products classified as Group 1 or 2 based on their risk level. Pursuant RDC 751/2022, the category of medi- cal devices is divided into four groups. • Group 1 and 2 – classified as low risk. These devices are required to be notified to ANVISA, following a simplified process that demands the submission of fewer documents (on aver- age, three documents). • Group 3 and 4 – classified as high risk. For these devices, a full registration procedure is required with ANVISA, involving the submis- sion of more comprehensive documentation (on average, five documents). Regarding importation, there is a distinction between registered and notified medical devic- es. Imported medical devices subject to regis- tration require the submission of proof of reg- istration, a certificate of free sale or equivalent document, issued by the competent authority of the country of manufacture and sale, as well as a declaration from the legal manufacturer. On the other hand, notified medical devices only require the declaration issued by the legal manufacturer. Finally, it is important to point out that in vitro medical devices have their own specific regu- lations, as set out in RDCs 830/2023 and 848/2024. Although they follow the same regu- latory process of notification or registration, the documentation required for these devices differs
from that applicable to others. 4.2 Regulatory Reliance
Brazil has embraced the notion of regulatory reliance. With RDC 741/2022, ANVISA recog- nises assessments by Equivalent Foreign Reg- ulatory Authorities (AREEs). Normative Instruc- tions (IN) 289/2024 and (IN) 290/2024 detail the
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