Submission Requirements for Medical Devices
For medical devices classified as Class I or II, the importer or distributor must:
• Pay an inspection fee to ANVISA
• Complete a registration form available from ANVISA
For Class III and IV devices, the importer or distributor must provide the following documentation:
• A copy of payment bank receipt provided by ANVISA
• Identification of the manufacturer or importer of medical device
• A copy of authorization of the manufacturer to import and market its medical device in the country
• A copy of registration or certificate of free trade or equivalent document issued by the competent authority where the product is manufactured or marketed
• A copy of the certificate of accomplishment of legal requirements determined by technical regulations, in the format of ANVISA’s legislation for medical products
• Documentation indicating that the device complies with the essential principles of safety and effectiveness established by Brazil
The Inspection Requirement
ANVISA announced that as of May 2010, it would require plant inspections of all medical device manufacturers marketing Class III and IV products in Brazil, and would no longer accept cGMP-QSR certificates issued by the U.S. Food and Drug Administration or ISO 13485:2003 certification (the latter necessary for CE Marking). Brazilian regulation, which came into effect in May 2010, set forth an inspection scheme for these manufacturers. In the event of a satisfactory result, the relevant company receives a certificate. In the case of a negative result, the procedure will be terminated and the manufacturer is not awarded a certificate. FDA is not contacted in either case.
Process Notes and Logistics
Inspection Schedule – Once the schedule has been confirmed, a copy of this schedule is sent to the importing company. The date arranged for the sanitary inspection will not exceed a period of 60 days following approval of the written application for the inspection to take place.
Carrying out the Inspection – The team responsible for carrying out the inspection will comprise two members of the technical staff of the Office of Inspection. After completion of the inspection in the relevant production plant, a technical report is drawn up containing information regarding the hygiene and sanitary conditions found in the plant and a conclusive recommendation for or against the issuing by the Brazilian Sanitary Surveillance Agency of the Certificate of Good Practice of Production and Control for the Purpose of Authorization. In the event of non-recommendation, the respective company is not awarded this certificate.
The final result of the inspection will be sent by the Office of Inspection and Control of Food Risks to the interested companies and to the General Office of International Affairs. The latter is responsible for dispatching the result to the sanitary authority of the country of origin.
Procedures for Inspection of Premises in the U.S. – The importer (with the approval of the producer in the case of a contract manufacturer) makes contact with ANVISA on the appropriate form and pays the relevant fee. After completing the inspection, the Foods General Office communicates the result of the same to the General Office of International Affairs of ANVISA and the interested companies, and the General Office of International Affairs informs the Sanitary Authorities of the country of origin of the result.