Regulatory Agency

Before an import license can be issued, the medical device must be registered with ANVISA.

The organization in charge of regulating medical device imports in Brazil is the Ministry of Health. In 1998 the Brazilian National Health Vigilance Agency (ANVISA), an agency similar to the U.S. Food and Drug Administration, was created to help monitor medical devices. All medical devices must be registered with ANVISA in order to be sold in Brazil.

Import Licenses

Only licensed importers can import products into Brazil. Import licenses are issued by the Foreign Trade Secretariat (SECEX) of the Ministry of Industry, Commerce and Tourism. The Brazilian import process operates through a computerized system called SISCOMEX (Sistema de Comércio Exterior or Foreign Trade Integrated System). The SISCOMEX process begins with the submission by a manufacturer of a pro-forma invoice ("fatura proforma") and a published list of prices or sales catalog from the supplier (if such exists). The original copy should be notarized, but need not be accompanied by a Chamber of Commerce certification or consular visa. The pro-forma invoice must contain the following information:

• Name and address of the manufacturer or exporter;
• A signed statement by the exporter or manufacturer verifying that the prices are current export market prices for destination to any country;
• If applicable, the name and address of the agent, distributor, representative, or concessionaire in Brazil, and a statement of commission due. This is not necessary when the agent has filed a general statement with SECEX of fees collected from a particular foreign firm. If no representative exists, this must be so stated
• Total f.o.b. price, unit price, gross and net weight, itemized freight and all other expenses, and total c.i.f. or c.i.f. value;
• If applicable, a statement declaring that published catalogs or price lists do not exist for the invoiced products.

Only companies based in Brazil can apply for product registration. Therefore, foreign manufacturers wishing to sell their products in Brazil must either register their products through a Brazilian subsidiary or a local agent or distributor. First, the Brazilian representative or distributor must contact the Ministry of Health and file with the intent of registering and licensing the product(s) it wishes to import. After the request has been approved, the equipment must be registered with ANVS. Registration of brand names and patented technology with the Brazilian National Industry Property Institute (INPI) is also recommended.

MD/IVD - GMP compliance 

An important change to the Brazilian medical device and In Vitro Diagnostic (IVD) regulatory processes.

On May 22, 2010, ANVISA, the Brazilian Health Surveillance Agency, will require manufacturers of high risk equipment and materials (classes III and IV); as well as high risk IVD products (classes II, III and IIIa) to comply with Brazilian Good Manufacturing Practices (GMP). Additionally, certain Class I and II medical devices, identified in Instrução Normativa 07/2009, must also meet this requirement.

Resolution RDC 25/2009, Article 2, delineates that the Good Manufacturing Practices certificate must be submitted with the registration application of medical devices as of May 22, 2010. The requirements for Brazilian GMP for medical devices conformity are outlined in RDC 59/2000 in the Diário Oficial da União; Poder Executivo. The Resolution is organized into the following categories:

• General Provisions
• Quality System Requirements
• Project Controls
• Control of Documents and Records
• Purchasing Controls
• Identification and Traceability
• Process and Production Controls
• Inspection and Testing
• Non-Conforming Products and Components
• Corrective Action
• Handling, Storage, Distribution, and Installation
• Packaging and Labeling Controls
• Records
• Technical Assistance
• Statistical Techniques
   

For manufacturers with devices already cleared by ANVISA in Brazil, Article 4 of RDC 25/2009 stipulates that the Brazilian GMP certificate must be presented for products already registered upon renewal of the registration, or when changes occur to the manufacturing site.

The implementation of this resolution will likely result in changes to the registration process and timeline, as ANVISA will be inspecting companies before issuing the Brazilian GMP certificate. Our colleagues in Brazil expect that ANVISA will require at least 60 days to schedule an inspection. The impact of these field inspections on the registration process should lessen as ANVISA hires more inspectors in the future.