Once a medical device is certified by ANVISA in the Brazilian market, the manufacturer or applicant needs to obtain a sales authorization in order to legally sell their product in Brazil. The following is an overview of the ANVISA Certified Sales Authorization for Medical Devices:
Application Process: After obtaining ANVISA certification, the manufacturer or applicant needs to submit an application for sales authorization to ANVISA. This usually requires the provision of relevant applications**, technical documentation, quality management system documentation, as well as product labels and instructions.
Review and evaluation: Anvisa will review and evaluate applications for sales authorizations. They will check the applicant's qualifications, product information, quality management system, etc., to ensure that the applicant meets the relevant regulations and requirements for the sale of medical devices.
Quality management system reviewSimilar to ANVISA Certification, the review of the sales authorization will also involve a review of the applicant's quality management system. This includes aspects such as production processes, equipment and facilities, personnel training, records and document management.
On-site audits: anvisa may conduct an on-site audit of the applicant's manufacturing facility to verify compliance with the requirements for the sale of medical devices. The audit may include production processes, quality control measures, product labeling, etc.
Product labels and instructionsThe application for sales authorization also needs to include the label and instructions of the product, ensuring that its content complies with Anvisa's regulations and requirements. Labels and instructions need to provide clear and concise product information, including use, how to use, precautions, etc.
Sales license issuanceOnce the application has passed the review and evaluation, ANVISA will issue a license for the sale of medical devices, allowing the applicant to legally sell their products on the Brazilian market. Sales licenses usually have a certain period of validity.
Updates and Maintenance: The license to sell medical devices is usually subject to periodic renewal. Applicants are required to submit an application for renewal before the license expires and ensure that their products continue to meet Anvisa's requirements and standards. In addition, applicants are required to comply with the relevant regulations of the sales license, such as recording and reporting requirements.
Supervision and inspection: Applicants holding a sales license are subject to supervision and inspection by ANVISA. This may include regular on-site audits, product sampling inspections, adverse event reports, etc.
In general, once a medical device is certified by ANVISA in the Brazilian market, it needs to obtain a sales authorization in order to legally sell it in that market. The application process for a sales authorization includes steps such as review and evaluation, quality management system review, on-site audit, product labeling and instructions, and issuance of a sales license. Applicants need to fully understand and comply with anvisa's requirements to ensure that their products are authorized for sale and are legally available for sale and use in the Brazilian market.