What do I need to adjust the size of my company with ANVISA?

The size of a company at ANVISA is directly related to its classification according to its turnover and the type of activity it carries out. ANVISA classifies companies into three main categories: Microenterprise (ME), Small Business (EPP) and Large Business. This classification influences not only tax obligations, but also the health and regulatory requirements that the company must meet.

To adjust the size of your company, it is essential to understand which category it currently falls into and whether there is a need to change it. For example, if the company's turnover has increased significantly, it may need to be reclassified from a Microenterprise to a Small Business. This change directly impacts regularization processes, such as issuing licenses and submitting specific documentation.

Adjusting the company's size with ANVISA requires the presentation of a series of documents to prove the information declared, here we will comment on just a few basic documents, the ideal is to contact a professional in the area. They are:

• Articles of association: It is necessary to present up-to-date articles of association, which should reflect the size of the company according to the turnover and activity carried out.
• Proof of turnover: Documents such as tax returns and financial statements are essential to prove the correct classification.
• Licenças e autorizações: Licenses and permits: Depending on the company's activity, it may be necessary to present health licenses already issued by ANVISA or other competent entities.
• Specific forms: ANVISA provides its own forms for requesting a size adjustment, which must be filled in and sent in accordance with the agency's instructions.

It is important to note that the documentation must always be up to date and in compliance with current regulations. Any inconsistencies can result in delays in the regularization process.

The process of adjusting company size with ANVISA is not easy and involves steps that must be followed carefully to ensure compliance. We've listed some of the necessary steps, but remember that the best way is to hire a specialized professional:

• Assessing current size: The first step is to assess whether the company's size is appropriate for its turnover and activity. If not, it is necessary to plan the reclassification.
• Gathering documentation: As mentioned above, it is essential to gather all the documents needed to prove the new classification.
• Applying to ANVISA: Formalize the application for size adjustment with ANVISA.
• Monitoring the process: It is important to monitor the progress of the process to ensure that there are no outstanding issues or requests for additional information.

Adjusting your company's size with ANVISA is a process that requires planning, organization and attention to regulatory standards. Understanding the company's current size, gathering the necessary documentation and following the steps for regularization are fundamental steps to ensure compliance with the agency's requirements. Keeping up to date with changes in the rules and relying on the support of specialized professionals can make this process easier, avoiding inconvenience and ensuring that your company operates within the law.

Stone Okamont has a team of executives and offers a specialized consultancy and advisory service to help you regularize your company, following the whole process closely and keeping you informed at all times. Ask for a quote!