How to regulate HIV self-test with ANVISA?

The risk classification of products by ANVISA (National Health Surveillance Agency) in Brazil is determined based on safety and efficacy criteria. The risk classification can range from I to IV, as follows:

• Risk Class I:

Products with low health risk.

• Risk Class II:

Products with moderate health risk.

• Risk Class III:

Products with high health risk.

• Risk Class IV:

Products with very high health risk.

In the context of HIV SELF-TESTS, the risk classification will depend on the specific characteristics of the product and its application. In vitro diagnostic products, such as HIV SELF-TESTS, are generally classified as Risk Class IV due to the critical nature of the results and their potential impact on public health. It is important to note that the exact classification may depend on the technical characteristics of the SELF-TEST, validation studies, and other specific product factors.

The regularization of an HIV Self-Test classified as Risk Class IV with ANVISA involves a series of steps and procedures. Here are the basic steps you can follow:

• Preparation of Technical Dossier:

Prepare a comprehensive technical dossier containing all necessary information about the product, including safety, efficacy, quality data, and other relevant aspects.

• Document Analysis:

ANVISA will conduct a documentary analysis of the technical dossier to verify if all information complies with current standards and regulations.

• Fee Payment:

Make the payment of fees related to the analysis and regularization of the product. The amounts may vary according to the type of product and the size of the company.

• Authorization Obtaining:

If ANVISA approves the technical dossier and deems the product suitable, an authorization for market commercialization will be issued.

• Post-Market Monitoring:

After authorization, it is important to continue monitoring the product in the market to ensure continuous compliance with standards and regulations.

Although the process of regulating an HIV Self-Test involves several stages, having the support of a company specialized in regulatory affairs can significantly simplify this procedure. Stone Okamont is a company that has trained professionals and extensive knowledge of current legislation. We offer specialized support, streamlining the regularization process to ensure that your company is in full compliance with applicable regulatory requirements.