All medical devices imported into or distributed within Brazil must first be registered with the Agência Nacional de Vigilância Sanitária, also known as ANVISA or the National Health Surveillance Agency.
The registration of most Class 1 and 2 devices involves a relatively simple application process – referred to as “cadastro,” meaning “abbreviated registration” – based on the low to moderate risk associated with devices in these classes. However, based on the greater degree of risk associated with their use, a more rigorous process applies to some Class 1 and Class 2 medical devices, as well as all Class 3 and Class 4 devices.
Documents required for submission in Brazil include a Trade Permit issued by the State, samples of labels and instructions for use translated into Portuguese, and a description of all manufacturing and quality control process steps. A Technical Report is required which includes a list of safety relevant components translated into Portuguese.
GMP certification based on an inspection conducted by ANVISA is required for registration (RDC No. 25, May 21, 2009). The GMP certificate must be submitted with the registration application for all Class III and IV devices, as well as for Class I and II devices noted on the Exemption List (Instruction IN-2, June 6, 2011). GMP inspections are also required to revalidate or update existing registrations. The GMP certificate is valid for two years, and ANVISA alone determines whether subsequent evaluations can be completed remotely through a paperwork audit.
Only companies based in Brazil can apply for ANVISA registration. Therefore, companies based elsewhere that do not have subsidiaries in Brazil must depend on Brazilian-based third parties, such as hosting companies, distributors and dealers, to obtain ANVISA registration for medical devices.
Under such an arrangement, ISA HEALTH offers foreign manufacturers, local third party hosting services, to hold the ANVISA registration.