World map image World's leading company for ANVISA and COFEPRIS product registration.
Anvisa product registration banner Ask for Quote
Doing Business In Brazil

To market health and beauty products in Brazil, you must first register with the appropriate local agency: ANVISA, (National Health Surveillance in Brazil).

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

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

This administratively complex 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.

Good To Know

Beyond navigating complex administrative issues, our work deals with a number of practices unique to Portuguese business culture:

  • Anvisa Registration must be requested through a Brazilian law firm that will own these records EXCLUSIVELY for five years;
  • The company must be in good standing and fully authorized by ANVISA.
  • This procedure is similar to that of the FDA.
  • The Anvisa registration process takes 6 to 12 months before your registration goes into effect;
  • he Anvisa registration is always held by the agency that filed the application.
Three Options Only

There are basically three ways to access the Brazilian market.

  • #1
    Having your own local branch (creation, merger/JV or acquisition): this approach involves the registration of your subsidiary and products in order to bring your products to Brazil. This option is usually slow and costly (medical staff hiring, etc.) and best justified for proven markets and businesses with high investment capacity and international infrastructure.
  • #2
    Using a local distributor: you will need to find and negotiate with a local distributor knowing that it usually carries several competing brands and often focus on one region or state. Statistically, this option most of the time, results in failure within 24 months and becomes very costly.
  • #3
    Joining forces with a trusted third party recognized by ANVISA, Mandala International (master distributor), get you up and competing faster and at much less cost with lower risk.

Creating a local subsidiary

1
Cost
High
  • Property Investment(s)
  • Employing a doctor and / or pharmacist.
  • Business trips.
Implementation
12 to 18 months
  • Creating a business structure.
  • Registering your affiliate.
  • Registering your products.
Risk Level
Medium
  • Legal risks.
  • Salery and wage risks.
  • Commercial failure risks.

Outsourcing to one of your local distributors

2
Moderate
  • Negotiating and ratifying a contract.
  • Often with a reference product and high commission.
  • Annual negociation.
10 to 12 months
  • Language and translation barriers in carrying out your requests.
  • Lack of responsiveness on the part of the distributor.
  • Lack of transeparency.
Very High
  • Legal risks(Brazilian contracts law).
  • Commercial risks.
  • (competing products).
  • Risks associated with the owenership of your registration. (exclusive rights).
  • Risks associated with exclusive distribution rights.

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

3
Low
  • Presentation of a clear and accurate estimate.
  • Fixed amount per product (with discounts for multiple products).
  • No commission or percentage of sales.
8 to 10 months
  • Expedited process based on access and established relationship with ANVISA.
  • Your own dedicated billingual contact.
  • Documentation and case management is included with our services
  • Transeparency and full autonomy.
Low
  • Contats conform to French law.
  • No salery, administrative or overhead costs.
  • Operated by a trusted third praty who can provide local assistance whenever you need it.
  • No exclusivly agreements .
  • We can propose several regional distributors.
Our solution offre ANVISA Bresil

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

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
#1
First Meeting and Personalized Consultation.
  • Presentation of our sales teams and techniques.
  • Examination and Corroboration of your penetration strategy, the products, and the market.
#2
Authorization to Carry Out a Preliminary Analysis
  • Securing and Assessing the legal and economic framework.
  • Pricing based on the number of products concerned.
#3
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.
#4
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.
#5
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.
#6
Procedure for registration or notification
  • Writing and developing appropriate presentation documents.
  • Validating certifications.
  • Filing and following up with relevant agencies.
#7
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.
#8
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
Download our Anvisa brochure

Contact 2 Lead is the Lead Generation service for Healthcare businesses that want to grow global. We provide customized list of qualified contacts to support your Sales & Business Development efforts and increase your revenues. With Contact 2 Lead you can prepare for your next trade shows by scheduling your appointments and sending emailing campaigns.

Other languages :

Our brochures for other services available

Download Cofepris brochure below :

Download Contact 2 Lead brochure below: