Brazil: Compliance

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Article
Reprocessamento de dispositivos médicos ganha consulta pública
Brazil's health regulator ANVISA has published four public consultations that fundamentally reshape the regulatory framework for medical device reprocessing, moving from a prohibited-products list to a risk-based validation system. The proposals shift responsibility for reuse decisions to healthcare facilities while imposing new labeling requirements and authorization obligations on manufacturers, importers, and processing companies.
Brazil Healthcare
KL
KLA Advogados
Article
CMN restringe aquisição de créditos judiciais e arbitrais por FIDCs
A partir de 13 de outubro de 2026, o Conselho Monetário Nacional estabeleceu novas restrições significativas para FIDCs e FIC-FIDCs na aquisição de créditos decorrentes de ações judiciais e procedimentos arbitrais. A medida exige que créditos possuam liquidez, certeza e exigibilidade em caráter definitivo, incluindo trânsito em julgado, impactando profundamente o mercado de special situations e legal claims no Brasil.
Brazil Finance
KL
KLA Advogados
Article
BRPTO Launches Call For Contributions On Fast-Track For Industrial Design Applications
The Brazilian Patent and Trademark Office has opened a public consultation on new regulations that would introduce fast-track processing options for industrial design applications, a mechanism not currently available in this category. The proposed framework includes priority pathways for elderly applicants, persons with disabilities, startups, litigation-related cases, and applications tied to patent filings or government permits, alongside a pilot project with quota-based allocation.
Brazil IP
LA
Licks Attorneys
Article
Lei Complementar 236/2026 altera penalidades e prazos no CTN
A Lei Complementar nº 236/2026 introduz mudanças significativas no Código Tributário Nacional, estabelecendo novos limites para multas tributárias, ampliando garantias dos contribuintes e uniformizando procedimentos administrativos fiscais em todo o Brasil. As alterações incluem vinculação da administração a decisões judiciais, redução de penalidades em diversas situações e padronização de prazos processuais.
Brazil Tax
KL
KLA Advogados
Article
Carbon Capture, Transport And Geological Storage: Decree No. 13,095/2026 Is Published, Regulating These Activities In Brazil
Brazil's Federal Government has issued Decree No. 13,095/2026, establishing a comprehensive regulatory framework for carbon dioxide capture, pipeline transport, and geological storage activities. The decree outlines technological routes including BECCS, CCS, CCUS, and DACCS, while designating the Brazilian National Agency of Petroleum, Natural Gas and Biofuels (ANP) as the authorizing body and integrating these activities with Brazil's Emissions Trading System for potential carbon credit generation.
Brazil Environment
MB
Mayer Brown
Article
BRPTO Opens Fast-Track Slots For IPC H04
The Brazilian Patent and Trademark Office has introduced new regulations allowing patent applicants to submit up to three fast-track requests per month for applications classified under IPC H04, marking a shift from the previous single-request limitation. While this change aims to improve access to expedited patent processing, questions remain about whether it adequately addresses the needs of innovation-intensive sectors like telecommunications and information technology that face ongoing challenges
Brazil IP
LA
Licks Attorneys
Article
Alerta de Julgamento: STF julgará a tributação, pelo PIS/COFINS, dos créditos presumidos de ICMS
O Supremo Tribunal Federal julgará em setembro de 2026 se empresas podem excluir créditos presumidos de ICMS da base de cálculo do PIS/COFINS. A decisão terá efeitos vinculantes para todos os casos sobre o tema e pode impactar significativamente empresas que aproveitam esse benefício fiscal. Contribuintes argumentam que tais créditos constituem patrimônio dos Estados para fomento empresarial e não devem ser tributados como receita.
Brazil Tax
KL
KLA Advogados
Article
CONAMA Resolution No. 516/2026 Published To Establish The “Brazilian RoHS”
Brazil's National Environmental Council has introduced Resolution No. 516/2026, establishing strict limits on hazardous substances in electrical and electronic equipment sold in the country. The regulation creates a mandatory national registry system and imposes compliance obligations across the entire supply chain, with varying implementation timelines ranging from immediate effect to four years depending on the substance. Non-compliance triggers recall procedures, environmental disposal requirements, and
Brazil Environment
MB
Mayer Brown
Article
STF inicia julgamento sobre proibição dos jogos de azar
O Supremo Tribunal Federal iniciou o julgamento sobre a constitucionalidade da criminalização dos jogos de azar no Brasil, mas o Ministro Flavio Dino pediu vista para ampliar a análise e incluir apostas esportivas (bets) e loterias. A discussão envolve a distinção entre jogos de azar tradicionais e apostas de quotas fixas, bem como os efeitos econômicos e sociais dessas atividades na sociedade brasileira.
Brazil Criminal
KL
KLA Advogados
Article
Extraordinary Secretariat For The Carbon Market Submits To Public Consultation A Draft Ordinance On The Timeline For The Implementation Of The MRV Obligations Under The SBCE
Brazil's Extraordinary Secretariat for the Carbon Market has released a draft ordinance establishing the implementation timeline for greenhouse gas emissions monitoring, reporting, and verification obligations under the country's new emissions trading system. The proposal outlines a three-stage rollout beginning in 2027, covering sectors from aluminum and steel production to transportation, with specific annual cycles for compliance that operators must follow.
Brazil Environment
MB
Mayer Brown
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