How to obtain the cadastral registration certificate (CRC)

A Cadastral Registration Certificate (CRC) is a document issued by the National Health Surveillance Agency (ANVISA) in Brazil, which proves that a company or organization is registered in the agency's system as a manufacturer, importer, exporter, distributor or storer of products subject to to health surveillance.

The cadastral registration is a mandatory requirement for companies that wish to request the registration of products subject to sanitary surveillance, such as medicines, health products, cosmetics, personal hygiene products, among others. The CRC is valid for two years and must be periodically renewed for the company to continue to exercise its activities in the sector.

The CRC is issued after the analysis of the documentation presented by the company, which must prove its fiscal, sanitary, and labor regularity, in addition to meeting other regulatory requirements.

The Cadastral Registration Certificate (CRC) issued by the National Health Surveillance Agency (ANVISA) serves to prove that a company or organization is registered in the agency's system as a manufacturer, importer, exporter, distributor or storer of products subject to health surveillance.

The cadastral registration is a mandatory requirement for companies that wish to apply for the registration of products subject to sanitary surveillance, such as medicines, health products, cosmetics, personal hygiene products, among others. In addition, obtaining the CRC is an important step towards regularizing the activities of these companies, ensuring that they are in compliance with the regulatory standards established by ANVISA.

The CRC is also important for consumers, as it attests that the company complies with health and regulatory standards, which increases the safety and reliability of the products sold by it. In addition, the CRC is an important criterion for assessing the company's suitability by regulatory and supervisory bodies.

Remember that cadastral registration is mandatory for companies operating in the area of ​​food, medicine, cosmetics, health products, among others. It is important to keep the registration updated to avoid problems with ANVISA.

Besides to the Cadastral Registration Certificate (CRC), the company needs to comply with other requirements of the National Health Surveillance Agency (ANVISA) to carry out its activities in the sector regulated by the agency. Some of these requirements include:

Product registration: the company must request the registration of its products subject to health surveillance with ANVISA. For this, it is necessary to present information about the quality, safety and efficacy of the products, as well as prove that they meet the regulatory standards established by the agency.

Licensing of companies: some companies need to obtain a health license to carry out their activities, as is the case with companies that produce, import, export or sell products subject to health surveillance. Licensing is a process that assesses the sanitary conditions of the company's facilities, equipment and production processes.

Operating authorization: companies wishing to sell products subject to health surveillance must obtain an Operating Authorization (AFE) from ANVISA. The AFE is a document that certifies that the company complies with the regulatory and health standards established by the agency.

Certification of good practices: companies that produce, import or distribute products subject to sanitary surveillance must comply with the Good Manufacturing Practices (GMP/BPF) and Distribution and Storage Practices (BPDA) established by ANVISA. The GMP/BPDA certification is a process to assess the compliance of these companies with the agency's regulatory and health standards.

Monitoring and control: ANVISA monitors and controls products subject to sanitary surveillance, verifying the quality, safety and efficacy of products sold in the country. Companies must comply with the regulatory and health standards established by the agency, as well as collaborate with inspections and inspections carried out by ANVISA.

We at Stone Okamont have expert consultants in regulatory affairs and with our personalized service we guarantee the delivery of results in a satisfactory manner and with reduced costs.

With a personalized service, Stone Okamont guarantees the success of your registration. We use our expertise to deliver results in a satisfactory manner, with reduced costs and zero bureaucracy.