Obtaining ANVISA-certified approval for a medical device in the Brazilian market is a complex process that usually includes the following steps:
Application PreparationApplicants are first required to prepare complete application materials, including technical documents, clinical trial results (if applicable), quality management system documents, labels and instructions, etc. Ensure that these documents meet ANVISA's requirements and standards.
Application Submission: Applicants submit their prepared application materials to Anvisa, usually through the ** platform or by post. Once submitted, ANVISA will conduct a preliminary review of the application materials.
Evaluation of technical documents: anvisa will conduct a detailed technical evaluation of the application materials, including the design, performance, safety and other aspects of the product. They may ask the applicant for further information or documents.
Quality management system review: anvisa conducts a review of the applicant's quality management system to ensure that it meets international standards and anvisa's requirements. This may involve an on-site inspection of the manufacturing plant.
Clinical trial evaluation: If the applied medical device requires a clinical trial, ANVISA will evaluate the results of the trial to determine the safety and efficacy of the product.
Label and instruction manual review: anvisa will review the labels and instructions of medical devices to ensure that they are clear, accurate and comply with relevant regulations and requirements.
License IssuanceAfter the review of the above steps, if the application is approved, ANVISA will issue a license for the medical device to be sold and used in the Brazilian market.
Supervision and UpdatesOnce licensed, applicants are required to comply with ANVISA's oversight and management requirements, including regular submission of product updates, quality reports, etc. In addition, the license of a medical device usually has a certain validity period, and the applicant needs to apply for renewal in time before the license expires.
The entire medical device ANVISA certification licensing process is usually a long and cumbersome process, requiring a lot of time and effort from the applicant to prepare and cooperate. However, once licensed by ANVISA, applicants can legally sell and use their medical device products in the Brazilian market.