Market Healthcare Products in Brazil

The ANVISA registration must be obtained before any commercial application for the following types of products:

  • Cosmetics
  • Medical Devices
  • Sanitary Products
  • Pharmaceuticals drugs
  • Food & Supplements

ANVISA General Guidelines

  • Anvisa Registration must be requested through a Brazilian company (Brazilian Registration Holder).
  • The Anvisa registration is always held by the agency that filed the application, EXCLUSIVELY for five years.
  • The company must be in good standing and fully authorized by ANVISA.
  • The Anvisa registration process takes 6 to 12 months before your registration goes into effect.

Three Options Only to access the Brazilian market

Cost Implementation Risk Level

Creating a local subsidiary


  • Property Investment(s)
  • Employing a doctor and / or pharmacist.
  • Business trips.

12 to 18 months

  • Creating a business structure.
  • Registering your affiliate.
  • Registering your products.


  • Legal risks.
  • Salery and wage risks.
  • Commercial failure risks.

Outsourcing to one of your local distributors


  • Negotiating and ratifying a contract.
  • Often with a reference product and high commission.
  • Annual negotiation.

10 to 12 months

  • Language and translation barriers
  • Lack of responsiveness
  • Lack of transparency

Very High

  • Legal risks(Brazilian contracts law).
  • Commercial risks (competing products)
  • Exclusive ownership rights of the license
  • Exclusive distribution rights.

Working with Mandala Brazil, a specialized hosting provider and Master Distributor.


  • Materialisation of a clear quote
  • Amount fixed per product and digressive
  • No success fee

8 to 10 months

  • Minimum time of instruction by ANVISA
  • Bilingual contact.
  • Writing and Project Management provided in our services
  • Transparency and total autonomy.


  • US law contract (or international)
  • No salary, structure or fixed costs
  • Registration held by a trusted third party driving the follow-up locally
  • No exclusivity, several regional distributors proposed

Market Veterinary and Agribusiness Products in Brazil

The MAPA registration must be obtained before commercialisation of following type of products:

  • Veterinary Products
  • Supplements/Whole foods/additives
  • Fertilisers/Pesticides
  • Seeds
  • Products from agriculture and livestock production

This administratively complex and unclear process involves a high level of risk.

Our services are intended to reduce this risk (commercial, legal and technical) by taking these time-consuming steps for you.

We aim to:

  • Become your regulatory partner
  • Be your administrative and commercial intermediary
  • Register your products and/or business using a local law firm
  • Keep and host your records and licenses
  • Offer pharmacovigilance and technovigilance services for your registered products through our own ANVISA approved laboratory.

This solution has many advantages:

  • You remain independent and autonomous
  • You choose all local distributors freely
  • You can determine for yourself when and how you want to sell your products
  • We take care of your regulatory and administrative requirements
  • We bring you the guarantee of a European organization with a solid team of professionals, that is respectful of legal and ethical principles.


While Brazil represents a growing market with a population of 250 million inhabitants, it is also one of the most complex, impenetrable, and time-consuming (administrative and protectionist) markets to navigate, one requiring considerable investment resources.

Our dedicated guidance is intended to illuminate and let you access this country’s business culture making it easier for you to make realistic and cost beneficial decisions, while at the same time leaving you free to choose your Brazilian distributors and buyers.

    Distributor Search (Optional)

  • 3 months survey
  • Meetings with future and potential partners, distributors, etc…for a week in Brazil

    First Meeting and Personalized Consultation.

  • Presentation of our sales teams and techniques.
  • Examination and Corroboration of your penetration strategy, the products, and the market.

    Authorization to Carry Out a Preliminary Analysis

  • Securing and Assessing the legal and economic framework.
  • Pricing based on the number of products concerned.

    Audit and Preliminary Findings

  • Determination of the product category (single, family, or system).
  • Definition of regulatory prerequisites (registration or notification).
  • Evaluation of classification within the definition of ANVISA, the National Health Surveillance Agency of Brazil.
  • Identification of other required certifications: – GMP or INMETRO
  • Clinical ests.

    Services and Contract

  • Determination of fees for necessary registration or notification.
  • Assessment of ANVISA taxes.
  • A five-year economic business plan for hosting.
  • Examination of all legal and regulatory requirements.

    Required Certification if applicable, such as a GMP.

  • Documented audit of manufacturing processes, production quality, and the supply chain.
  • Inspection of the physical facility, including its structure, condition, appearance, equipment, hygiene and safety, and any environmental or structural emediation if needed.
  • Preparation of technical report and recommendations.
  • Management meeting to present the report for approval.
  • Follow-up to review changes and recommendations.
  • Preparation and filing of paperwork and applications to obtain proper certificate(s).
  • Monitoring the application process to provide any additional information requested by ANVISA or other relevant agencies.

    Procedure for registration or notification

  • Writing and developing appropriate presentation documents.
  • Validating certifications.
  • Filing and following up with relevant agencies.

    Publication in Brazil’s “Official Journal of the Union”

  • Proofreading and reviewing the consistency of the release, as well as registration certificates.
  • Ensure the issuance of administrative documents.
  • Start selling your product.

    Monitoring and Securing Business Environment

  • Maintain records.
  • Alert you to changes in regulatory requirements and certifications.
  • Audit selected distributors to ensure legal compliance, ANVISA requirements and financial health.
  • Issue and track Import Letters.

Contact Us

Should you have any questions or request for information about our services, please fill out the form below. We will do our best to reply shortly.
Our sales team is attending most of major healthcare events across the world, it is also possible to request for a meeting in a specific trade show or congress.