Brazil Improves Device Assessment for National Health System
This is the report written by Molly Cohen from FDA News about my article regarding the regulatory changes in Device Assessment in Brazil.
A new Brazilian law requires using protocols and guidelines as part of enhanced assessment processes to increase access to medical devices through the country’s national health system, the Sistema Unico de Saude System (SUS).
Law 12.401, proposed by Brazil President Dilma Rousseff, which aims to improve the inclusion of devices in the SUS, will be implemented within the next six months.
It will improve access to high-quality devices that adhere to criteria based on clinical protocols and therapeutic guidelines created by health professionals from different SUS provisions, according to Latin America and Spain analyst for IHS Global Insight Ruben Gennero.
The law allows 180 days for manufacturers to demonstrate compliance with the new effectiveness, safety and cost-effectiveness criteria, with an additional 90 days for extension — an appropriate time to complete the safety and efficacy studies, Gennero said. It also includes a provision for consultation and public input.
Including Devices
The decision to include devices in the SUS will be governed by the National Commission of Technology Incorporation (Comissio Nacional de Incorporacio de Tecnologias, Citec); coordinated by the Ministry of Health and integrated by representatives from the Ministry, the National Agency of Supplementary Health (Agencia Nacional de Saude Suplementar, ANS) and the National Drug Regulator (Agencia Nacional de Vigilancia Sanitaria, Anvisa), as well as one member from the National Health Council and the Federal Council of Medicine, Gennero said.
But even though a reshaping of Citec’s capabilities and the inclusion of new members on the board will ensure transparency, there is also a risk of bureaucracy under the new assessment paradigm, Gennero warns. “The real impact will be measured when the law enters into force within the next six months.”
It introduces periodic assessments of medical technologies offered by the SUS. The assessment criteria cover standards for effectiveness, safety and cost as conditions for the inclusion of new products listed on the SUS, Gennero said.
This is the most recent change in a growing list of changes in Brazil that aim to improve medical device regulation. In April, Brazil’s Attorney-General of the Union restricted Anvisa’s power to examine applications of intellectual property rights on medical products and reduced its role to weighing in on the scope of health risks on the product seeking patenting (IMDRM, April).
Last month, ANVISA began charging inspection fees for certificates of compliance with good manufacturing practice (GMP) and quality control every two years instead of annually to clear up confusion stemming from a 2009 law that called for annual quality system inspection fees while the GMP certification is renewable on a bi-annual basis (IMDRM, May).
