Understand the essential steps for regularizing products with ANVISA and how QR Group can help your company ensure compliance quickly and safely.

If you work in the industry of products that require regularization with the health surveillance agency, you know that regularizing products with ANVISA is a crucial step, not only for marketing, but also for approval of entry into Brazil in import processes.

The National Health Surveillance Agency (ANVISA) is the agency responsible for ensuring the safety, efficacy and quality of products. Although the process may seem complex, QR Group is here to simplify each step and ensure that your company complies with all the necessary standards to thrive in the Brazilian market.

First steps: licenses and documentation

The first step to starting the process is to ensure that your company has the operating license from the city hall and the health license, in addition to the Establishment Operating Authorization (AFE), when applicable. This authorization is essential for your establishment to be able to operate in accordance with legal standards and with a safe structure. Without it, the regularization process doesn’t even begin!

With the municipal license in hand, the next step is to prepare the documentation for ANVISA, aiming to obtain the AFE. Organization and precision are essential in this process. Documents such as the Good Practices Manual, Technical Reports and Stability Studies are crucial for a successful submission.

Regularizing the product: registration with ANVISA

After the initial preparation, it is time to focus on registering the product with ANVISA. Your company must submit a dossier containing all the technical information about the product. The complexity of this dossier varies according to the product category, and technical knowledge is essential.

Proof of efficacy and safety is a common requirement. Clinical studies, laboratory tests and research data must be collected and presented in a detailed and accurate manner.

Approval time and monitoring

Patience is an important aspect of the process. ANVISA has established deadlines for analysis, but the waiting time may vary based on the volume of submissions and the complexity of the product. After regularization, it is essential to keep the registration up to date and ensure that any changes to the product or regulations are communicated quickly.

Now that you understand how the product registration process with ANVISA works and the importance of operating licenses, your company is better prepared to face this regulatory process. Although the path is detailed, successfully complying with the standards results in a great competitive advantage in the market.

Partnership with QR Group

QR Group is the ideal partner for companies seeking success in health regulations in Brazil. With our vast experience in the sector, we offer specialized consultancy for the regularization of health products with ANVISA, ensuring an agile and efficient process.

We are committed to providing effective results, and our expertise can be the difference your company needs to meet and exceed regulatory requirements. We invite you to explore QR Group’s services and find out how we can help your business succeed.

Contact QR Group and ensure that the regularization process for your products is smooth and successful!