The audit process for medical devices to be registered with ANVISA in Brazil is a complex and exhaustive process designed to ensure the safety, efficacy, and compliance with regulatory standards of the product. The following are the main steps of the review process for Anvisa registration of medical devices in general:
1.Document Submission and Preliminary Examination:The registration process begins with the company submitting an application for registration to Anvisa. Companies are required to submit all necessary documents and information through Anvisa's ** system. The preliminary review phase focuses on the completeness and compliance of documents, including technical specifications, quality management system documents, safety and effectiveness documentation, etc. If there are deficiencies or non-compliance, the company may need to provide additional information.
2.Technical Review:Once the initial review is passed, anvisa will conduct a technical review, focusing on the technical specifications, design and manufacturing information of the product. This stage of the review will ensure that the technical characteristics of the medical device comply with national and international standards. The examiner will carefully study the submitted documents to verify that the product complies with Anvisa's regulations and guidelines.
3.Safety and Efficacy Review:Safety and efficacy reviews are an important part of the review process to ensure that the product is safe for patients and users under normal use. This may involve the evaluation of the product's laboratory test results, prior clinical data, and other relevant information. anvisa will carefully examine the evidence provided by the company to ensure that the intended effect of the product is commensurate with its risks.
4.Payment of the Preliminary Registration Fee and Payment of the Examination Fee:During the audit process, the company needs to pay the initial registration fee and possible audit fees. These fees may vary depending on the product's classification, registration category, and audit workload. Companies need to ensure that all relevant fees are paid in a timely manner to avoid delays in the registration process.
5.Clinical trial review (if applicable):For some categories of medical devices, Anvisa may require clinical trials. The reviewer will carefully evaluate the clinical trial plan, conduct, and results provided by the company to ensure that the trial is designed and conducted in accordance with regulations and provides adequate safety and efficacy data.
6.Review Decisions:Upon completion of a technical, security and performance review, Anvisa will make a review decision. If all audit requirements are met and the product meets the relevant standards, the company will be approved for registration by Anvisa. If there is a problem or does not meet the requirements, Anvisa may make additional requirements or refuse registration.
7.Certificate of Registration Issuance:Once the audit decision is approved, ANVISA will issue a medical device registration certificate. This is a necessary document for the legal sale and distribution of products in the Brazilian market. The registration certificate contains the product's registration number, expiration date, and other important information.
8.Subsequent updates and regulation:Once the Certificate of Registration is obtained, the company needs to regularly update the registration information and comply with Anvisa's regulatory requirements. This may include annual reports, notifications of product changes, and other information that needs to be updated.
Throughout the review process, companies typically work with locally registered companies, who will assist companies in communicating with Anvisa, providing support, and ensuring the accuracy and completeness of the registration documents. This collaboration is important for the successful completion of the registration process.