High Performance


Health 4.0 – The Future is Now!

By Pedro Cassab* | Cassab Law Advogados
November 18, 2019

This was the theme discussed in Brasilia last November 6 in the auditorium of the National Health Surveillance Agency – ANVISA, in the event “20 years of Medical Device Regulation in Anvisa – next steps”.

In order to facilitate the dialogue between associations with other Government Sectors, the event was attended by the Director of Anvisa Renato Porto who reaffirmed the importance of responsibility within the institution’s activities, which regulates 22.7% of national GDP. “We will continue to work for another 20 years of balanced and proportionate regulation, with the ultimate goal of meeting the patient at the other end.”

Another highlight of the event was the Future Perspectives on Healthcare Control of Medical Devices. In this panel, Leandro Pereira, also director of Anvisa, pointed out: “More products, more petitions due to new technologies, but with budget constraints and less human resources in the Agency’s staff”. “We need to find efficient ways to bring agile and important solutions for everyone”.

Still the theme goes up: “the new reality requires norms that simplify the paths. As an example, Pereira cited the International Medical Device Regulators Forum (IMDRF) for global harmonization of standards, the Unique Device Identification (UDI) for medical devices and electronic documentation. “And the future is near: translated IMDRF clinical study and research documents will be for public consultation in the coming months. We need to work with international regulatory convergence because we want a competitive industry. And we have already built a very positive environment with industry associations. Because we only move, in a consistent and agile way, with the collaboration of all”.

The highlight was Anvisa experts on custom medical devices, newly regulated Agency products (RDC 305/2019), software regulation, and product cybersecurity debates in IoT and hyperconnection. General Data Protection Act, sanitary control and impacts of legislation on manufacturers and importers were other topics of discussion during the event.

Given the current scenario, manufacturers and importers should increasingly look not only at the regulatory approach coming from Regulatory Agencies such as Anvisa, Anatel and others, but to adopt a broader view of legislation with the aim of integrating the Regulation, Competitiveness and Safety triad into their day to day. For only in this way can they effectively establish a posture of control, competitiveness and safety in their operations.

*Pedro Cassab is a Lawyer and Founding Partner of Cassab Law – Advogados. Graduated in Law at Universidade Paulista, Ribeirão Preto, State of São Paulo – 2001; Specialist in Health Law from the Faculty of Medical Sciences, Universidade Estadual de Campinas, in partnership with the Institute of Applied Health Law, with the thesis “The Regulated Power of the National Health Surveillance Agency”– 2010; Lead Auditor (GMP) RDC 16 ANVISA, ISO 13485 and 21, CRF 820 FDA/USA GMP, São Paulo–2013; Post-graduated in Economic Law from the Faculty of Law of Ribeirão Preto, Universidade de São Paulo (USP) –2016/2017; Certified by the Institute of Regulatory Law (IPDR) in Regulatory Pharmaceutical Law, São Paulo – 2018; Member of the Health Law Study Group (GEDISA / USP) – 2020.

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