Health-related companies that wish to produce, store, distribute, and sell products in Brazil must register with the Brazilian Health Regulatory Agency, or ANVISA. The first step in this process is to obtain a Local Operating License from a local or state authority.
To help companies establish their operations in the Brazilian market, RAGB provides advisory and consultancy services regarding the ANVISA Local Operating License, guiding them throughout the entire process.
Importance of the Local Operating License
The Local Operating License is basic for registering your health company with ANVISA. Without this license, it is impossible to obtain an Operating Permit, Good Manufacturing Practices Certificate, and regulation certifications for your company’s products.
How Can I obtain a Local Operating License?
There are several steps in the process of acquiring this license.
You must verify that your local company’s National Classification of Economic-Fiscal Activities (CNAE) and articles of incorporation define your company’s operations in Brazil. This is necessary because in Brazil a company’s activities must be well-defined in its articles of incorporation. The CNAE is derived from the International Standard Industrial Classification of All Economic Activities (ISIC 4).
In this step, RAGB utilizes the company’s CNAE and description of activities and ensures that both comply with ANVISA requirements. RAGB can save your company time and money by expediting the process and reducing the potential for having to repeat work.
The Technical Assessment Report, also known as the Sanitary Assessment Report (LTA or LAS, in Portuguese, respectively), is a process in which we provide detailed information about the physical structure and production processes of your company, and an assessment is performed by an engineer or architect. During this process, floor plans and complete production specifications may be subject to audit by the local ANVISA office.
RAGB will guide your company through the entire assessment process. This includes advisory services from an engineer or architect regarding the necessary legal compliance, or a full assessment report service package that is completed by engineering professionals specializing in technical reports Implementing Quality Systems.
This phase is essential for companies in any category operating in the health area in Brazil. RAGB provides the necessary support to help you develop a quality system, including help with standards, manuals, forms, and procedures, in addition to tailoring the implementation of this system to your needs.
In addition to the process described above, other documentation is required by this health surveillance agency in the area where your company wants to do business. This may include a municipal master plan; a business license (if applicable); and a fire department permit (if necessary), among others. Once the documentation is complete, an inspection by the agency is requested.
At this inspection, the local health surveillance agency audits all the standards and regulations for your company. After the audit, the inspectors issue an inspection report and the agency grants a Local Operating License. The inspection report delivered to the federal agency ANVISA may not contain any non-conformities. Otherwise, it will not be possible to obtain an ANVISA Operating Permit (AFE) or product registration.
To ensure that the inspection is successful, RAGB prepares the entire company for inspection by the local health agency. This includes a pre-inspection of your facilities or manufacturing plants, and providing training for employees who will be audited. We also accompany the VISA inspectors, giving your company all the support it needs on the ground. We take care of any issues that arise regarding noncompliance, implementations and actions, and processes, among others. Our objective is to obtain a satisfactory inspection report, saving your company time and costs.