What regulatory steps does a company have to comply with in relation to ANVISA?

Regulating a company with the National Health Surveillance Agency (ANVISA) is essential for various reasons, primarily related to ensuring public health and complying with sanitary norms and regulations. Some of the main reasons why a company should be regulated with ANVISA include:

• Compliance with Laws and Regulations
• Ensuring Product Quality and Safety
• Protecting Public Health
• Credibility and Reliability
• Avoiding Penalties and Sanctions

Regulation with ANVISA is a legal and ethical responsibility for companies dealing with products and services subject to health surveillance. In addition to ensuring compliance with norms, it promotes the safety and quality of offered products, protects public health, and enables access to markets regulated by the agency.

The regulatory steps a company must go through with the National Health Surveillance Agency (ANVISA) can vary depending on the type of economic activity and the health-related products or services the company intends to develop or market. However, in general, some common regulatory steps that a company may need to comply with with ANVISA include:

Product Registration: If the company plans to manufacture, import, or market products subject to health surveillance, such as medicines, medical devices, cosmetics, personal hygiene products, among others, it is necessary to obtain the registration of these products with ANVISA. This registration involves the submission of technical documentation, clinical studies (when applicable), and compliance with specific requirements for each type of product.

Operating Authorization: If the company is involved in activities related to the storage, distribution, or transportation of products subject to health surveillance, it may be necessary to obtain a Company Operating Authorization (AFE) from ANVISA. This authorization proves that the company is qualified to carry out its activities in accordance with sanitary norms.

Good Manufacturing Practices: For companies that manufacture products subject to health surveillance, such as medicines and medical devices, it is essential to follow Good Manufacturing Practices (GMP), which are technical regulations that ensure the quality, safety, and effectiveness of manufactured products.

Good Distribution and Storage Practices: Companies involved in the distribution and storage of products subject to health surveillance must also adhere to Good Distribution and Storage Practices (GDP) to ensure the integrity and quality of products throughout the logistics process.

Specific Authorizations: Depending on the company's activity, it may need to obtain specific authorizations from ANVISA, such as authorizations to conduct clinical research with new products or to change the composition of already registered products.

Compliance with Norms and Regulations: The company must comply with all applicable ANVISA norms, regulations, and resolutions related to its activity. This includes compliance with technical, sanitary, labeling requirements, among others.

It's worth noting that regulatory steps can be complex and vary depending on the type of company and activity. It is essential for the company to consult current legislation and seek specialized assistance to ensure compliance with all ANVISA requirements correctly and in accordance with applicable norms.

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