Doing Business 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

Good To Know

  • 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

High

  • 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.

Medium

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

Outsourcing to one of your local distributors

Moderate

  • 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.

Low

  • 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.

Low

  • 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

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
  • Import and distribute your products (medical devices, cosmetics, pharmaceutical, dental, sanitary products, and drugs.)

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.

MANDALA Brasil also offers two additional benefits, with our customized service

Studying and Finding the right Distributors for you

Do you want to better understand the market before you decide to invest there?

MANDALA Brasil delivers a specific six months assignment, including:

  • A study of the market and specific business opportunities .
  • Research and a selection of the best regional distributors (solid, reliable and authorized by ANVISA), specializing in your products.
  • A study of financial and regulatory issues.

Our service includes a week in Brazil conducting face-to-face meetings with qualified local distributors and / or potential partners.

Assessment and Quality Management

Do you worry that your business must obtain a Certificate of Good Manufacturing Practice and approval by ANVISA?

Because registration of your local subsidiary or distributor is required every two years, your company must maintain Certificate of Good Manufacturing Practice. An extremely detailed audit of the tools and methods of production you employ is conducted on your premises by ANVISA.

MANDALA Brazil will perform a preliminary audit, complete with a technical report detailing our recommendations to guarantee compliance with all ANVISA requirements. (See Our Procedures page).

Procedure

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. 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.

A proven approach,

safe and secure


safe and secure Brazil represents a huge potential market with very strong growth (PIB > 2Mds US $, population of 200 million, and was just ranked the world’s sixth largest economy). But, it is also a complex and impenetrable market with strong protectionist regulations, which require substantial financial resources.

    First Meeting and Personalized Consultation.

  • 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: – INMETRO, the National Institute of Metrology for products containing electronic components. – Certificates of Good Manufacturing Practice for registration requests.
  • 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 Certificate of Good Manufacturing Practice.

  • A preparatory meeting with ANVISA for an in-office consultation.
  • 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 health2.
  • Issue and track Import Letters.