With a population of more than 190 million people and a number of medical device companies interested in conducting business in its maturing healthcare system, Brazil represents the largest medical equipment market in South America and one of the largest markets in the world. To conduct business there, manufacturers will face a progressive regulatory approvals system (including mandatory device registration). Because the Brazilian market represents such a significant prospect, orthopaedic device manufacturers can benefit from understanding the regulatory requirements and the registration and certification process for their products. This article explains the Agencia Nacional de Vigilancia Sanitaria (ANVISA) foundation upon which the regulatory framework is established. I call upon years of defending this challenge to orthopaedic companies to help explain the logistics of planning for and administering this type of inspection.
Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically manage inspections conducted by ANVISA (Created by Law # 9.782). This Brazilian Agency was established in 1999 to control medical devices classified as high risk. (In Brazil, health products such as devices are categorized into four levels of risk, I and II being low risk, and III and IV classed as high risk.) ANVISA is designated an autonomous agency operating under a special regime. This means that ANVISA is an independently administered, financially-autonomous regulatory agency managed by a Collegiate Board of Directors, comprising five members. Presently, there are more than 3,300 medical devices manufacturers registered worldwide with ANVISA to enable the import of their medical devices into Brazil. In order to import and distribute a medical device in Brazil, the medical device must be registered with ANVISA. The length of time between filing an application for registration and final approval by the government varies, but often takes three months to two years to complete, depending upon the complexity of the device and the quality and sufficiency of information accompanying the submission.
The institutional purpose of the agency is to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. Sanitary surveillance of imported orthopaedic devices embraces premises and manufacturing processes, as well as the range of inputs and technologies concerned with the design and development. ANVISA is strategically aligned with the priorities of the Brazilian Foreign Affairs Policy (PEB) and the guidelines of the Brazilian Health Policy to:
• Promote solidarity among nations
• Focus on strengthening partnerships with other countries
• Strengthen institutional representation with other Regulatory Agencies
• Promote new spaces for regulatory cooperation
• Promote the exchange of information and experiences between regulators and World Health Organization (WHO) regional offices
Presently, ANVISA focuses inspections on medical device companies manufacturing products of class risk III and IV. (Risk classification based on GHTF guideline SG1-N15:2006)