Fukuma Advogados & Consultores

Medical devices

  • Viability analysis for the product, under Brazilian legislation;
  • Regulatory consulting for the obtainment of registry within ANVISA under current legislation;
  • Regulatory consulting in registry renovation;
  • Regulatory consulting and advising in attending demands and monitoring registry and post-registry processes within ANVISA;
  • Regulatory sanitary consulting on the making of processes for the obtainment of local licenses, federal working authorization and/or renovation;
  • Company and technical officer’s regularization within Professional Monitoring Councils;
  • Consulting and advising on the proceedings of sanitary infraction notices;
  • Elaboration of administrative defenses and appeals;
  • Regulatory consulting in demands’ compliance;
  • Scheduling of hearings with ANVISA;
  • General consulting in regulatory sanitary matters;
  • Consulting in processes for international inspection under current legislation;
  • Previous inspection in international plants to check for compliance with Brazilian sanitary legislation;
  • Regulatory advising in the drafting of Best Practices Manual;
  • Consulting on current legislation for implementation of Quality System.