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.