Soluto Regulatórios acts in the orientation, analysis and preparation of dossiers for settlement products in order to ensure the viability of marketing with quality, speed and safety.

With experience in notification, cadaster and product registration at ANVISA and MAPA, Soluto Regulatórios team is competent to carry out work with all classes of products, respecting the particularities in conducting processes for each customer.

  • Initial regularization of domestic and imported products
  • Cadastres, registrations and notifications
  • Technical framework and grouping
  • Definition of strategies for product regularization
  • Technical and regulatory feasibility analysis

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RDC No. 687/2022


New criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices. On 05/18, Resolution - RDC No. 687/2022 was published in the Official Gazette [...]