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 , 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.