The National Health Surveillance Agency (ANVISA) participated in the Medical Device Single Audit Program (MDSAP) Forum and the Regulatory Authority Council (RAC) meeting held in Essen, Germany, from June 24 to June 28, 2024. The event gathered representatives from 27 countries, including MDSAP member medical device regulatory authorities, observers, affiliates, MDSAP auditing bodies, and the medical device industry.

During the forum, new affiliate members were welcomed, including the Health Sciences Authority of Singapore, Mexico, and Kenya. The RAC Chair, currently held by the Australian authority, presented the strategic priorities of the MDSAP and provided updates on ongoing projects. The forum also featured panels dedicated to various stakeholders, including affiliate members, observers, founding members, industry representatives, and auditing bodies.

Brazil was represented by the Medical Device Inspection and Supervision Management and the International Affairs Advisory Office of ANVISA. They presented advances in the use of MDSAP reports and certificates for issuing the Agency’s Good Manufacturing Practices Certificate (CBPF). The next in-person RAC meeting is scheduled to take place in conjunction with the International Medical Device Regulators Forum (IMDRF) meeting in Seattle, USA, in September 2024.

Source: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-participa-do-mdsap-2024-e-da-reuniao-do-conselho-de-autoridades-reguladoras-rac-forum

Region: Brazil

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