BRAZIL IS THE LARGEST MARKET FOR MEDICAL DEVICES IN SOUTH AMERICA
With a population nearing 210 million, Brazil represents the largest market in South America for medical devices and also one of the largest in the world.
In addition, Brazil has a very mature regulatory program in place. Brazil is a member of the Southern Common Market, also known as MERCOSUR, which partially harmonizes the regulations with Argentina, Paraguay and Uruguay. All medical devices sold in Brazil must register with the Agência Nacional de Vigilância Sanitária (ANVISA), which is an independently administered, financially autonomous regulatory agency responsible for the regulation and oversight of medical devices. ANVISA maintains the registered products database and performs all registration and inspection functions within the agency.
Companies must be based in Brazil to register with ANVISA, so companies exporting to Brazil must work with an in-country entity, such as a distributor or dealer.
Device classification in Brazil is based on risk and is similar to that used in the European Union. Class I and II devices have a relatively simple application process, which sometimes varies depending on device use.
Higher risk devices may be required to provide all or some of the following documentation with their application:
June 23, 2016: Guidance Document: Guide for Preparing the Technical Dossier of Medical Products for Registration: RDC No. 40/2015
February 9, 2017: Technical Note 008/2017-GEGAR / GGGAF / DIGES / ANVISA – Updated Sanitary Surveillance Inspection Fees
April 26, 2017: Resolution (RDC) No. 153/2017: Rules on the Classification of the Degree of Risk for Economic Activities Subject to Health Surveillance for Purposes of Licensing, and Other Matters
April 26, 2017: Normative Instruction (IN) No. 16/2017: The List of National Classification of Economic Activities (CNAE) – Classified by Degree of Risk for the Purposes of Health Licensing