Once a medical device is registered with ANVISA in Brazil, the company may need to make some changes after the product is marketed. Changes may involve product design, manufacturing, labeling, packaging, quality management systems, etc. Before making any changes, companies need to understand and comply with Anvisa's change management regulations to ensure the safety, effectiveness and compliance of the product.
The following are the main aspects of change management for the registration of medical devices ANVISA:
1.Change Definition:Any changes that may affect the safety, effectiveness, performance, or specifications of a product after registration with Anvisa should be defined and classified. Changes can be substantial, such as changes to the product design, or minor changes, such as changes to labeling or packaging. Companies need to have a clear understanding of which changes fall within the scope of what must be reported to Anvisa.
2.Change Classification:Depending on the nature of the change, Anvisa divides it into three categories: Class I (low-risk change), Class II (medium-risk change) and Class III (high-risk change). Class I changes may only require internal records, while Class II and Class III changes usually require advance notice or approval from Anvisa. Companies need to be aware of the specific regulations and requirements for different categories of changes.
3.Internal Records:For some minor or low-risk changes, Anvisa may require the company to keep internal records without prior notice or approval. These records need to include a description of the change, the rationale, the date of implementation, and any verification or test results related to the change. The purpose of internal records is to ensure that the company is able to provide a history of changes when needed.
4.Advance notice:For medium risk changes (Class II), companies are generally required to notify Anvisa in advance. The length of advance notice depends on the nature of the change and is usually 30 to 60 days. Advance notification includes a detailed description of the change, the rationale, the planned implementation date, and the actions the company has taken to ensure that the impact of the change on the product is minimized.
5.Change Request:For high-risk changes (Class III), companies are required to submit a change request to Anvisa and wait for approval from Anvisa. The change request needs to include a detailed description of the change, rationale, implementation plan, risk assessment, and possible verification or test results. Anvisa will review the change request and approve or reject the change once the requirements are met.
6.Risk Assessment:Whether it's internal records, advance notice, or change requests, companies need to conduct a risk assessment. A risk assessment will help companies identify the potential impact that changes may have on the safety and effectiveness of a product. This helps companies take appropriate measures to mitigate risks and ensure the continued safety and effectiveness of their products.
7.Communication with anvisa:During the change management process, companies need to maintain active communication with Anvisa. This may include responding to questions from anvisa, providing additional information or explaining the reasons for the change. Proactive communication helps build transparency and ensures a good working relationship between the company and Anvisa.
8.Report after completing the changes:Once a change has been implemented, companies are usually required to submit a change completion report to Anvisa. This report needs to include information such as a description of the change, the date of implementation, and the results of validation or testing. This helps demonstrate that the company executed the changes as planned and that the safety and effectiveness of the product is maintained.
Overall, change management after the registration of medical devices with ANVISA is a critical step in ensuring the continued compliance of the product. Companies are required to strictly comply with Anvisa's regulations and report and approve changes in a timely manner to ensure that the products continue to be sold legally in the market.