Regulatory affairs - ANVISA Registration in Brazil

HOSTING SERVICES - Registration Holder Service (Medical Devices, Cosmetics and Food)

Foreign medical device and cosmetics manufacturers or distributors / exporters that do not have a Brazilian branch must appoint a Brazilian Registration Holder – BRH. This company acts as a link between your company and National Health Surveillance Agency – ANVISA and is responsible for your registration in Brazil. Amaral & Cia, with offices in Brasilia – BRAZIL and Miami – USA, can act as your BRH.

How to enter the Brazilian market immediately, reduce the cost of registration and still have the freedom to choose your importers and distributors?

Amaral & Cia simplifies the entry of foreign products Medical devices, cosmetics and food products in the Brazilian market, making them (your company’s products) more competitive.

The first step of this process is product registration with the National Health Surveillance Agency (ANVISA) on behalf of the Amaral & Cia. We possess all authorizations, permits and certifications for registering products with ANVISA.

We are responsible for maintaining the registry during its term (5 years) with exclusive use of your company and clients (distributors) specified by you.

Furthermore, if our client has interest, Amaral & Cia has all the necessary documentation to perform direct imports and distribution.

Faster Results

We’re already approved by ANVISA, so we don’t need to wait for permits and licenses. This means an alleviation of at least 12 months in the process of entry into the Brazilian market.

Freedom to Replace Importers / Distributors

As holders of registration of the products your company has complete freedom to negotiate with importers / distributors, ensuring greater flexibility and security to your business. For every importer identified, Amaral & Cia will give permission to import using Amaral & Cia’s product registration. Your company has TOTAL control of the operation.

Support and legal certainty

Amaral & Cia respects the principles of Brazilian and US law, the integrity of Lawyers, ethical and moral principles and American anticorruption legislation.

Agility in the Release of Registrations

With over 21 years of experience in the regulatory area, our team has acquired the know how necessary to drive the process of product registration with efficiency and agility.

Summary

• Product registration under the name of Amaral & Cia with all the rights due exclusively to the contractor and his/her authorized representatives. In other words, the registry is YOURS;

• Agility; It is not necessary to wait years for the opening and registration of the company in Brazil;

• The registration will be valid for 5 years;

• You do not need to be physical CONTRACTING company (Moulds ANVISA) in Brazil, which means economy in regulatory terms, (starting a business, physical structure, framework for technical assistance, technical manager, rent, staff, etc.) easily exceeds USD 35,000.00 monthly. After 5 years this will represent USD 2,100,000.00;

• You may have representatives in all Brazilian states using the registration on behalf of Amaral & Cia;

• Afterward, if contractor was to create a branch in Brazil and register the product under their own name, there will be no legal fees towards the regulatory procedure.

In order to assist your company on products registration with ANVISA (National Agency of Health Surveillance), Amaral & Cia provides qualified and experienced professionals who will take care of the whole bureaucratic part of the processes. This service involves updated specialists according to the constant changes of legislation and internal processes of ANVISA, and will guide your company since its required documents compilation until the publication on the Official Gazette of the Union. Amaral & Cia still counts on the service of processes renovation of registrations.

Our Services:

1- PRODUCTS FOR HEALTH (CORRELATIONS)

• 1.1 – Registration of medical usage equipment and items;

• 1.2 – Registration of In-Vitro Diagnosis products;

• 1.3 – Registration of family of products for health;

• 1.4 - Notification / Registration of products;

• 1.5 – Renovations of registration;

• 1.6 - Petitions/Changes;

• 1.7 – Technical translations;

Services available for the following category of products:

Products for Health – (Correlations)

• Sets, reagents and inputs destined to diagnosis;

• Medical-hospital equipment and materials;

• Equipment for image diagnosis;

• Dental equipment;

• Hemotherapeutic and laboratory diagnosis equipment;

• Radio-isotopes for in-vivo diagnosis;

• Radiopharmakons and radioactive products used in diagnosis and therapy.

Equipment of health usage – classifications grades I and II subject to registration (IN N. 07/2010)

Electrical equipment under Health Surveillance regime including their parts and accessories:

• Ones destined to esthetics and embellishment, and having as functioning way the application of energy or substances in a potentially dangerous way, considering the nature and place of application of the energy or substance;

• Ones destined to medical, physiotherapeutic and dental usage, that are connected to electrical wired or have an internal source of energy, and that provide direct contact with the patient

• Apparatus for disinfection of medical products; (and/or sterilization)

• Apparatus for sterilization of products for embellishment or esthetics;

• Apparatus for sterilization of medical products;

• Freezer and refrigerators for blood bags, human biological tissues, organs destined to transplants in humans and fluids to be managed in the human body;

• Centrifuge for blood bags;

• Processor of blood components;

• Heater for blood bags;

• Surgical Microscope;

• Software that provides processing of medical images;

• Automatic equipment for diagnosis in-vitro as: biochemical analyzer, glucose measurer, etc.;

• Active applicator of medicines such as insulin applicator, hormones applicator, etc.;

• Reprocessor of hemodialyzers;

• Surgical pneumatic motor.

Materials for usage in Health:

• Products subjected to compulsory certification (condoms, gloves for procedure, etc.);

• Products comprised of liquids, gels, pastes or creams;

• Components, wires for dental care;

• Equipment for blood and derivatives;

• Equipment for infusion pump;

• Filters for hepatic dialysis;

• Filters for hemodialysis;

• Filters for removal of blood derivatives;

• Suture wires;

• Instruments destined to invasive or surgical usage to cut, Pierce, saw, milling cut, file, scrape, clip, remove, tweeze, or execute any other similar procedure, with or without connection to any active medical product;

• Contact lens;

• Masks for special usage (type N95);

• Implantable materials on teeth (i.e.: resins, amalgams, cements and cores);

• Implants measurer;

• Systems for apheresis without plastic bags;

• Clinical thermometer;

• Radiological protection clothes;

• Circuits for extracorporeal;

• Components of dental implants.

2 - COSMETICS AND HYGIENE AND PERFUME PRODUCTS

• 2.1 – Registration of cosmetics grade II;

• 2.1 – Notification of cosmetics grade;

• 2.3 – Free sale certificate;

• 2.4 – Renovation of registration grade II;

• 2.5 - Petitions/Changes;

Cosmetics, hygiene and pergume products:

• Hydrogen peroxide 10 to 40 volumes (including the creamy ones, except for medical usage products);

• Axillary antiperspirant;

• Feet antiperspirant;

• Tanning activator/ accelerator;

• Infantile lipstick and lip gloss;

• Sun Blocker / anti solar;

• Infantile Blush/ rouge;

• Tanner;

• Simulator tanner;

• Skin whitening;

• Chemical whitening for nails;

• Whitening for hairs and body hairs;

• Infantile Cologne;

• Anti-dandruff / anti-hair loss conditioner;

• Infantile conditioner;

• Anti -cavity toothpaste;

• Anti-plaque toothpaste;

• Anti-tartar toothpaste;

• Whitening toothpaste/ chemical dental whitening;

• Toothpaste for sensitive teeth;

• Infantile toothpaste;

• Chemical epilator;

• Hair bleaching;

• Axillary Antiperspirant Deodorant;

• Feet Antiperspirant Deodorant;

• Intimate Deodorant;

• Anti-plaque mouth rinser;

• Antiseptic mouth rinser;

• Infantile mouth-rinser;

• Anti-dandruff / anti-hair loss rinser;

• Infantile hair rinser;

• Coloring hair rinser;

• Chemical “peeling” defoliant;

• Infantile nail enamel;

• Infantile hair fixer;

• Pre-soaped wipes for Infantile Hygiene;

• Makeup with photoprotector;

• Infantile cleaning/sanitizing product;

• Product to smooth and/or dye hair;

• Product for the eyes (except for make-up and/or moisturizer action and/or makeup remover);

• Product to avoid chewing fingernails;

• Product to undulate hair;

• Product for acneic skins;

• Product for wrinkles;

• Product for children’s skin protection;

• Lips protector with photoprotector;

• Sun cream;

• Infantile sun cream;

• Cuticle remover;

• Nicotine stain chemical remover;

• Insect repellant;

• Antiseptic soap;

• Infantile soap;

• Intimate usage soap;

• Infantile Talcum / starch;

• Talcum / antiseptic powder;

• Temporary / progressive / permanent hair dyeing;

• Hair Tonic / lotion

• Anti-dandruff / Anti-hair loss shampoo;

• Coloring shampoo;

• Anti-dandruff / Anti-hairl oss conditioner shampoo;

• Infantile conditioner shampoo;

• Infantile shampoo;

3 – SANITIZERS AND DOMESTIC SANITIZERS

• 3.1 – Registration of sanitizers grade II;

• 3.2 - Notification of sanitizers grade;

• 3.3 – Free sale certificate;

• 3.4 – Renovation of registration grade II;

• 3.5 - Petitions/Changes;

• 3.6 – Technical translations;

Sanitizers

• Bleach;

• Algaecides for pools;

• Disinfectants;

• Water disinfectant for human consumption;

• Deodorants;

• Sterilizers;

• Fungicides for pools;

• Insecticides;

• Amateur gardening and Repellents;

• Biological products;

• Domestic sanitizers and such (caustic, corrosive);

• Domestic sanitizers with antimicrobial activity,

• Rodenticides.

4- FOOD

• 4.1 – Registration of food;

• 4.2 – Notification of food;

• 4.3 – Certificate of free sale;

• 4.4 – Renovation of Registration;

• 4.5 - Petitions/Changes;

• 4.6 – Technical translations;

• 4.7 – Evaluation of claims in marketing material and packaging of food

• 4.8 - Evaluation of requirements meeting of legislation in force of formulas and labels of national and international food products

Food

• Food with functional property or health allegations;

• Infantile food;

• Food for Enteral nutrition;

• New technology packaging (recycled);

• New food and new ingredients;

• Bioactive substances and isolated probiotics with functional properties and/or health allegations.

5 - MEDICINES

• 5.1 – Registration of new medicine;

• 5.2 – Registration of similar medicine;

• 5.3 – Registration of new concentration and/or new pharmaceutical form;

• 5.4 – Renovations of registration;

• 5.5 – Technical translations;

• 5.6 - Petitions/Changes;

Medicines (Pharmakons)

• Specific Medicines

• New Medicines;

• Similar Medicines;

• Generic Medicines;

• Registration of Biological and Hemotherapic Products;

• Active Pharmaceutical Input (IFA).

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