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    • / Products and Services / Regulatory Affairs Management

    Products and Services

    Regulatory Affairs Management

    Subordinate to the entity’s Executive President, the Management of Regulatory Affairs has as peers the other management areas of the association, and aims to support, contribute to, and execute the strategies defined by the association for the Regulatory Affairs area while respecting and maintaining full alignment with ABIMED’s strategic axes.

     

    ACTIVITIES

    • Keeping up with ANVISA’s initiatives, proactively contributing to the Regulatory Agenda; following and promoting the association’s Cooperation Agreement with the agency; participating in Working Groups; promoting periodic meetings with technical areas such as GGTPS, GGFIS, GGPAF; following up on meetings of the Collegiate Board of Directors; contributing to and participating in seminars, sectorial dialogues, and discussions promoted by the agency; participating in meetings of international regulators within the scope of SGT-11 MERCOSUR and IMDRF;
    • Keeping up with INMETRO and ANATEL initiatives with respect to conformity assessment of medical devices, participating in public consultations and technical groups;
    • Engaging with other entities in the defense of the medical devices industry;
    • Fostering international Regulatory Convergence through the activities in MERCOSUR, IMDRF, the Inter-American Coalition for Regulatory Convergence, and interaction with international associations such as DITTA, GMTA, MedTech Europe, ABHI, ADVAMED, and others;
    • Following up publications on the Federal Gazette and others related to regulations and laws that affect health surveillance and distribute the information to the associates;
    • Promoting and following up the building of ad-hoc Working Groups to discuss Public Consultations and/or new regulations. Formulating and consolidating the associates’ contributions and sending them to the relevant body(ies);
    • Preparing a program of seminars and workshops related to the regulatory area, meeting the demand from associated companies and/or important subjects in the scope of Saber ABIMED;
    • Interacting in the regulatory arena with other medical device industry associations;
    • Following up on the activities of the relevant ABNT committees;
    • Following up on Foreign Trade issues that may affect the medical devices market;

     

    PROJECTS

    • III INTERNATIONAL FORUM OF MEDICAL DEVICES 2023 – an event held with other industry associations where ANVISA participates and technical issues in the regularization of medical devices, especially implantable ones, are presented and discussed.
    • MEDICAL DEVICES DAY AT ANVISA – event held at ANVISA’s headquarters together with other industry associations where regulatory trends, industry vision are presented and which promotes regulator-regulated interaction to promote communication and social participation.
    • INITIATIVES OF THE INTER-AMERICAN COALITION ON REGULATORY CONVERGENCE – representation of the associates before the Coalition and participation in activities that promote convergence and good regulatory practices in the Western Hemisphere.

     

    COMMITTEES / TOPICS ADDRESSED

    • Regulatory Intelligence Committee: Regularization of medical devices. Claims, proposal of standards; participation in Public Consultations, Sectorial Dialogues, and other initiatives of social participation.
    • Committee on Compliance Evaluation Programs: discussions on INMETRO and ANATEL certification and homologation regulations for medical devices. Claims, proposal of standards; participation in Public Consultations, Sectorial Dialogues, and other initiatives of social participation.
    • LATAM Regulatory Intelligence Committee: Regularization of medical devices in Latin America. Follow-up of the countries, pleadings, norm propositions, eventual participation in Public Consultations, promotion of presentations about the countries in the region.
    • Who can participate: Regulatory and quality professionals from associated companies.

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