Operating Permission

For a company to work in the Medical Devices field it is mandatory to obtain an Operation License (AFE) granted by ANVISA. 

 Setty assists companies in all stages of their regularization, offering full support from the early stages to reach their full commercial regularization.

Registration

After obtaining the Operating permission, it is mandatory to register the Medical Device in ANVISA. 

After publication in the Brazilian Official Gazette (D.O.U) the registration holder is allowed to manufacture and/or import Medical Devices in Brazil.

Services Provided by Setty in Medical Devices field

• Local Operating Permission;
• ANVISA’s Operating Permission (AFE) for industries, importers, distributors, carriers;
• Alteration, Expansion, Reduction of Activities in the Operating Permission (AFE); 
• Medical Device registration
• In vitro Diagnostic Products registration;
• Medical Device Registration Renewal;
• Medical Device’s Post Approval alterations;
• Good Manufacturing Practices Certification (GMP/CBPF), Good Storage and Distribution Practices Certification (CBPAD)