Operating Authorization (AFE)
The ANVISA authorization that unlocks your operation with safety and compliance.
WHO DO WE SERVE?
Distributors / Importers (wholesale trade)
Aesthetic, dental, and medical clinics
Transport companies, warehouses, and logistics operators
Manufacturers
Other establishments subject to the oversight of the Health Surveillance Agency.
CLIENTS
The key to operating legally in regulated markets, with agility and compliance
The Operating Authorization (AFE) is one of the essential documents required for your company to operate in markets regulated by ANVISA. Without the AFE, your company is not authorized to carry out activities such as distribution, importation, storage, transportation, or manufacturing of regulated products such as medicines, cosmetics, healthcare products, food products, and others.
DSL Consult offers a complete service for obtaining the Operating Authorization (AFE), with a focus on agility, compliance, and organization, ensuring that your company is regularized in accordance with current legislation and ready to begin operations without legal risk.
Empresas que atendemos
Empresas que atendemos
What Is the Operating Authorization (AFE)?
The AFE is an official document issued by ANVISA that authorizes a company to carry out specific activities according to the type of product or service it provides.
This document defines the scope of the company’s operation within sanitary legislation, establishing which activities are permitted, such as:
Product manufacturing
Distribution
Import / export
Storage and transportation of regulated products
Holding an AFE means that your company is authorized by ANVISA to operate within sanitary and safety standards and may act legally in the market, without the risk of suspension, fines, or other penalties for operating irregularly.
The Operating Authorization (AFE) is essential for companies working with products or services regulated by ANVISA. It is recommended for:
Distributors and importers of medicines, cosmetics, healthcare products, food products, and other regulated items
Industrial companies and manufacturers that require AFE for production and distribution
Transport and logistics companies involved in the supply chain of regulated products
Expanding businesses that need AFE for new addresses or changes in business activity
If you are starting your operation or are already in the market and want to regularize your activity with ANVISA, the AFE is the first step to ensure your company is legally compliant and ready to grow without restrictions
Ensure excellence
Who is this service recommended for?
Businesses in cosmetics, medical devices, healthcare products, sanitizing products, food, pharmaceuticals, and other sectors regulated by ANVISA.
Business owners, startups, distributors, manufacturers, and professionals looking to regularize their operations or acquire already-regularized companies.
Specialized consulting for transport companies that wish to operate with products subject to health surveillance regulations, ensuring compliance at every stage of the operation.
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Companies We Serve
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Who We Support
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Transport Companies
Practical Benefits
Legal and regulatory security
With the AFE in place, your company has the assurance that it is operating within the rules and under ANVISA’s authority, reducing legal and operational risks.
Agility throughout the process
DSL Consult ensures that the AFE application process is handled efficiently, without compromising documentation quality, helping reduce the risk of formal requirements and delays.
Greater trust and credibility
With the AFE, your company conveys credibility and trust to partners and clients, showing that it is regularized and prepared to operate transparently and legally.
Frequently Asked Questions
“Is the AFE the same as the Sanitary License (LS)?”
No. The AFE is the federal authorization issued by ANVISA that allows certain regulated activities to be performed, while the Sanitary License (LS) is issued by the local Health Surveillance authority (municipal or state) and is required to validate the operation of the physical establishment.
“How long does it take to obtain the AFE?”
The timeline varies depending on the type of activity and the documentation submitted. On average, the process may take between 30 and 90 days, but DSL Consult works to make the process as fast as possible without compromising quality.
“Can I operate without an AFE?”
No. Without the AFE, your company cannot legally operate in activities regulated by ANVISA, which may result in fines and even suspension of operations.
