ANVISA (National Health Surveillance Agency) is the regulatory body responsible for ensuring the safety of products that impact public health in Brazil.
To be a registration holder, it is necessary to have a company that is legally established in Brazil, inspected by State or Municipal Health Surveillance, and authorized by ANVISA through the issuance of a Company Operating Authorization (AFE) to manufacture and/or import products such as food, cosmetics, sanitizing products, medical devices, and medicines. Learn how to choose a hosting service for your company: How to choose a Hosting Service for your company .
In this article, we will discuss the main responsibilities of a registration holder with ANVISA and the regulations governing these activities.
1. Application and Maintenance of Registration
It all begins when the company holding the AFE (Company Operating Authorization) submits a product registration application to ANVISA. This process requires the submission of complete documentation, including safety and efficacy data, in accordance with current regulations and the risk classification of each product. Learn more about risk classification in the following articles: How to Regulate Medical Devices with ANVISA and Notification and Registration of Medical Devices: Differences, Classifications, and the Importance of Regulatory Compliance
The main regulation governing product registration is Law No. 6.360/1976, regulated by Decree No. 8.077/2013. These regulations form the foundation for the registration and commercialization of health products in Brazil.
Key Responsibilities:
- Submit all necessary documentation to ANVISA, including technical reports and quality studies.
- Ensure the product complies with the safety standards set by the agency.
- Renew the registration within the deadline, preventing the loss of authorization to commercialize the product.
2. Post-Market Monitoring of Non-Medicinal Products
After approval and commercialization, the registration holder is responsible for continuously monitoring the safety and quality of the product. This is particularly important for products such as medical devices, food, and cosmetics.
Main regulations:
- RDC 894/2024: Establishes safety criteria for cosmetic products and regulates the process of monitoring these products’ safety in the market.
- RDC 595/2022: Sets rules for the monitoring and technovigilance of medical devices, as well as the notification of adverse events related to these products.
Key responsibilities:
- Notify ANVISA of any adverse events or technical issues related to the product.
- If necessary, carry out recalls ensuring consumer safety and inform ANVISA and the public of any potential risks.
3. Compliance with Labeling and Advertising Standards
The registration holder must ensure that products are properly labeled and that all advertising complies with ANVISA’s standards. This is essential to prevent misleading consumers about the product’s characteristics or benefits.
Applicable regulations:
- RDC 907/2024: In addition to addressing cosmetic product safety, this RDC regulates mandatory information on cosmetic labels, such as ingredients, usage instructions, and precautions.
- RDC 17/2008: Regulates the advertising of medicines and health products, serving as a reference to avoid exaggeration or misleading claims in advertisements for over-the-counter products (although it primarily focuses on medicines).
Key responsibilities:
- Ensure that label information is clear, accurate, and compliant with ANVISA’s labeling standards.
- Adhere to advertising standards, avoiding exaggerations or misleading claims about the product.
4. Good Manufacturing and Distribution Practices
The registration holder must ensure that both the manufacturing and distribution processes follow Good Manufacturing Practices (GMP) and Good Distribution and Storage Practices (GDSP). This ensures that products reach the end consumer with the same quality and safety established during registration.
Applicable regulations:
- RDC 658/2022: Establishes GMP requirements for health products, ensuring they are manufactured under appropriate quality control. Although more focused on medicines, Good Practices also apply to other products subject to health surveillance, such as medical devices.
- RDC 497/2021: Establishes regulations for the distribution and storage of health products, including medical devices and other products regulated by ANVISA. Its goal is to ensure that products maintain their quality until they reach the end consumer.
Key responsibilities:
- Maintain quality standards throughout the entire production and distribution chain.
- Conduct internal and external audits to ensure that all partners comply with quality and safety regulations.
5. Technical Responsibility
The registration holder must appoint a technical responsible person with specific qualifications to oversee the product’s quality. This person communicates directly with ANVISA on behalf of the company and ensures compliance with all regulations, as required by Law No. 6.360/1976 and Decree No. 8.077/2013.
Key responsibilities:
- Keep the technical responsible person updated and duly registered with ANVISA.
- Ensure that this person is qualified to oversee quality and safety control activities.
Conclusion
Being a registration holder with ANVISA involves a series of fundamental responsibilities to ensure that products are safe for consumers. From registration application and maintenance to labeling and ensuring good manufacturing practices, the holder must strictly follow the established regulations.
Staying compliant with these obligations is essential to avoid regulatory issues and ensure that your product remains available on the market.
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