Get Introduced to the Government

Avoid losing time and money registering products with ANVISA in Brazil




Background: while working as the National Coordinator for the Medical, Pharmaceutical and Cosmetics Industries in Brazil, from 1997 until the year 2000, Mr. J. Clovis Lemes assisted the Brazilian Health Authorities in its reform of the regulatory system.

Beyond his high workload of commercial promotion activities, Clovis also lead CS Brazil in tracking and reporting to DOC headquarters on the Government of Brazil's implementation of a new "FDA-type" Sanitary Vigilance Agency (ANVISA). This constantly changing Brazilian regulatory structure not only raised numerous questions and trade complaints from U.S. exporters concerned about the high fees of product registration, but also captured the concern of DOC's Undersecretary for International Trade. In response, Clovis authored a number of reports outlining these regulatory changes and co-led Brazilian Government delegations to the United States to meet with USG counterparts and U.S. private sector about these issues. Clovis has received high commendations from USG agencies in Washington and U.S. industry for these efforts.

In the Year 2000, Mr. Lemes returned to the private sector and in partnership with these solution providers, he has been assisting international companies with their needs for product registration with the health authorities, and the ministry of agriculture in Brazil. The following is a summary of the best possible way to have your products registered in Brazil, and how to avoid the “local ownership of registration issues”.



The Law and ANVISA's Role

Attention! This is new! Brazilian medical device market regulator ANVISA now accepts only electronic submissions of petitions for importation of devices.

Brazil ANVISA electronic submission of medical device import petitionsAccording to a new directive, RDC 74/2016 (link in Portuguese), ANVISA’s device importation process has moved to a wholly electronic system known as ViCOMEX as of May 31, 2016. The ViCOMEX system was designed to provide a single platform through which medical device importers can submit all necessary documentation and avoid any delays more common with manual petition processes.
Foreign manufacturers and importers must now follow the following process:

ANVISA supervise many areas, which encompasses a universe of 450 medical drugs industries, 2,100 drug wholesalers, 65,000 Private pharmacies and supervision of 2.5 billion units of drugs per year. Filling of any documents must be made directly AND ONLY to ANVISA's Public Servicing Unit ("Unidade de Atendimento ao Público, in Portuguese), known as UNIAP. This can be done in person or through mail, according with Resolution - RDC nº 124, of May 13, 2004.

As set out in article 12 of Law nº 6,360, of September 23, 1976, the “products of interest to health” (Produto de Interesse à Saude, in Portuguese), may be it made in Brazil or imported, may be industrialized, exposed to sale or delivered for consumption in the Brazilian market ONLY AFTER their registration with the Ministry of Health. Without the registration, the product cannot be advertised or sold in Brazil. The exception to this are those referred to in § 1 of Article 25 of the above-mentioned Law, which although exempt from registration, are subject to health surveillance (listed products). Manufacturers without a subsidiary in Brazil, which intend to sell medical devices in this country must obtain representation by a Brazilian Registration Holder (BRH) recognized by ANVISA. The BRH is responsible for all communication and registration activities with ANVISA.

Violation the Law determinations constitute infringement of Federal Health Legislation and the infringing company will be subject to the penalties stipulated in Law No. 6,437 of August 20, 1977, without prejudice to any penalties applicable be it criminal or civil in nature. In the legal sphere, the Technical and Legal Officials of the infringing companies will respond by their actions, according with the infractions and penalties provided for in article 273 of Decree Law No. 2,848 of December 7, 1940 (Penal Code-Chapter III: Crimes Against Public Health).

Law No. 9,782 of January 26, 1999, article 8, granted powers to the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, in Portuguese) – Anvisa, to regulate, control and monitor the products and services that involve risk to public health, which include, among other activities, the provision of product registration (section IX of article 7 of Law No. 9,782/99). Risk classification based on GHTF guideline SG1- N15:2006.

The registration and listing of products with Anvisa are regulated by specific resolutions in accordance with the nature of each one.

The registration or listing must be done through an electronic petition to Anvisa, comprised of documents and information indicated in the Anvisa’s RDC No 185/01 and other relevant laws, and is thus a “documentary process”. The registration request is based on Anvisa’s RDC No. 24/09. The process is analyzed by Anvisa’s technical body that will decide on the acceptance of the petition, and/or may request additional information and documents when needed. The granting of the registration or listing is done through the publication of the acceptance in the Official Gazette (DOU, in Portuguese).

Product registration at Anvisa is a numeric sequence composed of 11 numbers, of which the first seven correspond to the number of the Company's Operating Authorization (AFE, in Portuguese), and the last four are sequential numbers, according to the ascending order of registrations granted to the same company. In this way, each registration is represented by a single numerical sequence.


The listing number of the products has the same formation, except for the last four digits, whose set always starts by the number 9 (nine). In this way, by analogy, the listing number has the following format XXXXXXX 9YYY1, where the seven digits correspond to the number of the company's AFE and the last three are sequential, obeying the order of increasing registration granted to the same company.

The overall products registration with Anvisa follows these actions. Obviously, this is dependent upon the type of products being registered or listed.

Note: Among the above requirements, special attention should be paid to the TECHNICAL REPORT. This is mentioned on Administrative Act 71/96 (and further additions), and which requires from the cosmetics, vitamin, and pharmaceutical manufacturers:

  1. Complete description of the product's formula, with all the components specified by their chemical designation, and the quantities of each one of them expressed in the metric system;
  2. Information on the function of each component, and its function as integral part of the formula;
  3. Name of the components according to the Pharmacopoeia Standards, Brazilian and International Compendia or attached bibliography, discussing the component and pertinent literature, including safety rules and efficacy. This information must be translated into Brazilian Portuguese.
Types of Product Registrations

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There are two types of regularization of products by Anvisa: the registration and/or listing. Listing is a simplified procedure of regularization, being applicable only to the products defined by Anvisa RDC No. 24/09, belonging to Classes I and II. However, it should be noted that some equipment, although under Classes I and II, are registered due to their nature and risk offered. To verify if an equipment must be registered, even if they are covered in Classes I and II, you must check the list published by Anvisa through Normative Statement. Auxiliary lists are also available at Anvisa's electronic site at: Electronic List.

Medical equipment subject to registration, if not listed, is in Classes I, II, III and IV. They may appear in any one of the eighteen classification rules, according to nomination and use.

For registration purposes, ANVISA classifies products in the categories below. However, be aware that often times this classification is subject of “interpretations” by ANVISA’s technicians, hence the need for a good registration agent:

1. Medical Devices.

“Medical equipment under health surveillance” shall include all equipment in the health, medical, dental, laboratory or physiotherapy sectors used directly or indirectly for diagnosis, therapy, rehabilitation or monitoring of human beings and, with the purpose of beautification and aesthetics. Medical equipment are entered into the category of health products, formerly called “correlated” (Correlatos, in Portuguese), in conjunction with articles for use in health and diagnostic products for in vitro use.

Medical equipment is composed, for the most part, by active implantable or non-implantable medical products. However, it may include non-medical equipment, such as for example, wheelchairs, stretchers, hospital beds, surgical tables, chairs for examination, among others.

The legislation for medical equipment is Anvisa’s Resolution RDC No. 185 of October 22, 2001, although complementary laws are used in this process. Specifically for the registration of medical equipment risk Class I and II, in addition to Anvisa’s RDC n° 185/2001, it is included the Normative Instruction No. 13 of October 22, 2009. As for listing, the applicable legislation is Anvisa’s Resolution RDC No. 24 of May 21, 2009.

Medical device manufacturers must apply for product registration at ANVISA. For medical devices falling under the scope of IEC 60601-1 and for some other non-active medical devices, INMETRO (National Institute of Metrology, Standardization and Industrial Quality) certification is a prerequisite in order to obtain ANVISA registration. ANVISA uses the net of accredited laboratories under the ‘International Laboratory Accreditation Cooperation’ - ILAC. Technical Analysis made by Anvisa is based on International Standards and Risk Analysis. These labs can carry out the annual factory inspection, which is required in order to achieve INMETRO certification, which is mandatory for certain devices registration. The list includes such items as gloves and condoms.

2. Medical drugs for human use.

For ANVISA, specific medical drugs fall into the following categories:

The requests and dossiers are organized in a chronological order in “line” (from the older to the newest, considering the filing date with ANVISA). The analyses of one request can be prioritized by the Agency considering Public Health Policy, as established on RDC 28/2007. Analyses of innovative drugs (new therapeutic indication, new pharmaceutical forms, new concentration, new associations), takes an average of 12 months.

(2.a) The solutions of large and small volume Parenteral fluids or not, such as:

(2.b) Medical drugs such as:

Vitamins and/or minerals and/or amino acids, isolated or associated with each other, with at least one of the components ABOVE the limits established by "nutrient Resolution" - RDC No. 269 of September 22, 2005. Please, note that the Brazilian RDA is much LOWER than in the USA. This was a way for the Brazilian-based manufacturers of vitamins, nutraceuticals, to "protect" the Brazilian market, by using a lower RDA. Note: the registration procedure for vitamins and minerals, isolated or associated elements is regulated by Ordinance SVS/MS No. 40 of January 13, 1998, and follows the technical regulation established by resolution RDC No. 132 of May 29, 2003.

Restrictions:

Medicated products categorized above cannot be registered as Similar or generic drugs. Important: efficacy and safety should be proven by clinical trials, reports or publications, for specific medicines and vitamins – opotherapeutic drugs – exempt from prescription.

The registration procedure of hemodialysis polyelectrolytes concentrates (CPHD) is regulated by Anvisa's Resolution RDC No. 8 of January 2, 2001 and follows the technical regulation established by resolution RDC No. 132 of May 29, 2003.

The registration procedure of oral rehydration products is regulated by Ordinance No. 108 of July 25, 1991 and follows the technical regulation established by resolution RDC No. 132, May 29, 2003.

The registration procedure for parenteral nutrition is governed by the Ordinance 272 of April 8 of 1998, and follows the technical regulation established by resolution RDC No. 132 of May 29, 2003.

The registration procedure for high-volume, parenteral solutions are regulated by Ordinance SVS/MS No. 500 of October 9, 1997 and follows the technical regulation established by resolution RDC No. 132, May 29, 2003.

The registration procedure for small volume parenteral fluids solutions is regulated by resolution RDC No. 9/2001 and follow the technical regulation established by resolution RDC No. 132 of May 29, 2003.

(2.c) Registration of Other Pharmaceutical Drugs

The Medical drugs category is divided into three distinct areas:

New Drugs: An innovative drug that has patent protection and whose efficacy, safety and quality have been scientifically proven and identified by its brand. This is how ANVISA defines this:

1. A product resulting from:
a) an alteration in the concentration of active substance or of its pharmacokinetic properties
b) an active substance not registered for the purpose for which it was intended
c) withdrawal of the active component of a product already registered
d) substitution of the active component of a product already registered.

  1. A product resulting from new molecular entities.
  2. A new salt, despite the corresponding molecular body having already been authorized.
  3. Two or more active unregistered substances, combined in the same product.
Similar Drugs: The documents required are the same as those required for registering a new product, with the exception of Document 5 (therapeutic test report). This should be replaced by a report that must be drawn up in accordance with Resolution 4/78 of the Medicines Technical Chamber, of the National Health Council, the requirements of which are set out below:

POINTS TO BE TAKEN INTO ACCOUNT IN DRAWING UP THE REPORT (RN 4/78 OF CTM/CNS)

Generic Drugs: Medication similar to a reference product or innovative product with which it is intended to be exchangeable, generally produced after the expiry or waiver of patent protection or other exclusive rights, with its efficacy, safety and quality having been scientifically proven, and named in accordance with the Common Brazilian Name Listing (DCB) or the Common International Name Listing (DCI).

Legislation:

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3. Cosmetics, personal hygiene products and perfumes.

Classified according to the health risk they may present, hence the need to register (or exempt) certain products.

Product registration:

TThe Resolution for registration of personal care products, cosmetics and Perfumes, or registration changes has been updated by resolution RDC No. 211 of July 14, 2005. The main modifications of the new resolution are related to technical requirements and Compulsory Labeling - Annexes III and IV, respectively. The components of the formula in the technical data and label shall follow these European Union guidelines: http://ec.europa.eu/enterprise/cosmetics/cosing/

Resolution No. 79 of August 28, 2000 was not fully revoked, and Annex III continues in full force (list of coloring agents allowed). Companies importing and/or manufacturers of personal care products, cosmetics and perfumes, located in Brazil shall implement a system for Cosmetics Vigilance in accordance with Resolution RDC No. 332 of December 1, 2005.

Product Notification (Listing):

Cosmetic “risk 1” products: The classification of products subject to notification has been updated by resolution RDC No. 211 of July 14, 2005 – Annex II – item I, which sets out an indicative list of products Risk 1. Defined as products with minimal risk, such as soaps; shampoos, toothpastes and deodorants; beauty/facial lotions, grooming products. These products no longer need registration, and do not incur administrative fees. However, companies must notify the Agency by using the appropriate form while the product can only be launched on the consumer market 30 days after this notification has been sent. Companies must follow RDC No. 343 of December 13, 2005.

Aimed at reducing bureaucracy and improving processes of health control actions for the protection of the health of the population, an electronic procedure for the notification of personal care products, cosmetics and Perfumes of Degree 1, was instituting by resolution to apply from 1/1/2006. Companies importing and/or manufacturers of personal care products, cosmetics and Perfumes, installed in the national territory shall implement a system for Cosmetic Vigilance in accordance with resolution-RDC No. 332, December 1, 2005.

Cosmetic “risk 2” products: Defined as products that present potential risk, such as: hair colors; hair straighteners; products for hair and scalp treatment (anti-dandruff shampoos); chemical depilatories; insect repellents; and products for children. The company must register the product, pay the administrative fees and wait for the registration approval.

4. Food (including beverages, bottled waters, food additives).

Products that DO NOT REQUIRE registration with either ANVISA or the Ministry of Agriculture (Annex I, Resolution RDC 23 of 3/15/2000):

Products that REQUIRE registration with either ANVISA or the Ministry of Agriculture (Annex I, Resolution RDC 23 of 3/15/2000):

In case of beverages and products of animal origin, in most cases, despite the company having to be enrolled and registered with ANVISA, registration of the products must be done with the Brazilian Ministry of Agriculture (MAPA, in Portuguese), which also has its own regulations for registration and supervision of food products. The Ministry of Agriculture is not part of the National Health Surveillance System. However, the MAPA works in conjunction with ANVISA throughout the food chain through its Secretariat for Agriculture Defense and the Department of Inspection of Animal Products (SIF).

This is the legislation in the food area, in addition to Decree-Law 69/986:

The Ministry of Health classifies vitamins or mineral supplements as food that complements the daily food supply of a healthy person, in cases when its ingestion from the regular food is insufficient, or when the meal requires a supplement. Those products must contain a minimum of 25 percent and a maximum of 100 percent recommended daily values of vitamins or minerals. In addition, these products are not intended as food substitutes or considered alternative meals.

Vitamins and minerals must be sold as:

Note: The Ministry of Health defines isolated or associated vitamins and minerals according to the Brazilian and other officially recognized Pharmacopoeias and the Food Chemical Codex.

The products may contain solvent, coloring, or sweetener, but must not be mixed with synthetic additives. It is necessary that the therapeutic effect of the herbs originate from the plant, its extract, juice, or oil, not from another ingredient in the formula.

In Brazil, for registration purposes, phytotherapy products are classified according to the length of time they have been used in the local or international market. There is one classification for traditional products, those that have been present in the market for over 30 years, and another for new products. When the product cannot be classified as a traditional phytotherapy drug, ANVISA demands clinical and toxicological tests to ensure its safety and efficacy. CONAFIT, the National Sub commission of Phytotherapy, is responsible for analyzing the requests for registration of phytotherapy products.

The following products are considered traditional herbs and are exempt from clinical tests: Artichoke, Aloe Vera, Chilean Boldo (Peumus boldus), Calendula, Chamomile, Ginger, Peppermint, and Common Balm, Passion Fruit, Alexandrian Senna and Garlic.

Teas are exempt from compulsory registration. The importer is required to submit a form to ANVISA, called “Importation of Products Exempt from Compulsory Registration”. Nutritional Supplements, Herbs, Minerals and Vitamins must be registered with the Ministry of Health. The steps of product registration for cosmetics and medicines in this area are practically the same.

Phytotherapy products: Unlike in the United States, products based on herbs must have a special registration in order to be sold. Even though manufacturers state that phytotherapy drugs need no special requirement, since they are produced with active ingredients obtained from fruits, meat, dairy, and greens, ANVISA notes that the substances present in pills and liquids are in a higher concentration than they appear in nature, which justifies their concern about potential side effects of these drugs.

Current regulation offers two possibilities to register a phytotherapy product: as a traditional drug or as a new product. For a product to be considered a traditional drug, it needs to have been used for more than 30 years while not producing side effects. A subsidiary or a manufacturer's representative must submit the application for registration for the Brazilian importer.

In the event that there is more than one importer of the same product, each importer must present a separate application. Foods, additives, technical supporting factors and packaging should be in accordance with Decree Law 986 of October 21, 1969, and respective regulations. When the importer or the manufacturer's representative operates from a commercial office, the sanitary permit (or permits) or operating license (or licenses) of the premises where the product(s) to be registered will be stored must be made available.

Product registration may take more than one year, depending on its complexity (particularly for pharmaceuticals). The Brazilian law specifies 90 days for registration or refusal. The documentation presented for registration, alteration or revalidation of the registration will be assessed by ANVISA, which will issue its decision through publication in the Federal Government Gazette (DOU - Diário Oficial da União).

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5. Household products: Registration is no longer needed for products ranked as “no-risk” or “risk 1”, which are defined as products offering minimal risks to human health. The registration shall be processed based on evaluation and management of the involved risks. The following aspects shall be taken into consideration when evaluating such risks (and here this is subject to ANVISA technician’s interpretations, which might not agree with your own testing methods at home): the toxicity of the substances and their concentration in the product; the purpose of use; the conditions under which they shall be used; the occurrence of previous problems; the population likely to be exposed to such products; the exposure frequency and its duration and the form of product presentation.

6. Cigarettes, cigars, and tobacco products.

7. Others: Any product that might cause health risks, that utilizes genetic engineering or from any other procedure subject to sources of radiation.

Note: The relevant classification criteria is defined on the basis of product usage purposes, affected body areas, directions for use and precautions to be taken when using such products. Brazil does not yet have an OTC (Over the Counter Product). Thus, sometimes it is very hard to classify an OTC product with the Brazilian legislation. Most of them are considered by the Brazilian legislation as pharmaceutical or cosmetic products.

Questions and Answers

Many international companies willing to register their products in Brazil contact us with their questions. One of the issues is that of "registration ownership". As informed above, the registration of a product with ANVISA is granted only to the COMPANY LOCATED IN BRAZIL. Therefore, the only way of you owning your registration is if you have your office in Brazil, and then we file your registration process using your local company's CNPJ (Brazilian Company Registration Number), which is unique to your local company. We prepared this Q&A, which might be beneficial to you, when analyzing this market:

Q. Does ANVISA allow “product families”?

A. To be considered "family" or group of equipment as specified in the resolution Anvisa RDC No. 97 of November 9, 2000 all models in the family must be manufactured by the same manufacturer and has the following characteristics:

There is no limit for inclusion of family models of equipment, provided that all meet the requirements indicated above. The fee for registering equipment family is superior to single equipment record. The family register of equipment is also possible, with the same rate for single equipment registration.

Q. How long does it take to register a product in Brazil?

A. This is a frequent question, given ANVISA's slowness in registration. The first thing you should know is that Brazil is under Civil (Roman) Law, not English Law. Therefore, in this Law System, bureaucracy is brutal, and a maze of legislation exists for everything. The Brazilian law specifies 90 days for registration or refusal. The time in registering a Class I, II (considered low risk) by ANVISA is approximately 3 to 4 months. ANVISA approval for products in class I-IV, which require GMP - Good Manufacturing Practices Certification as part of the device registration application ranges from 6-12 months in general. This period of time is for preparation of all registration and technical file, along with the document translations, as all documents submitted must be in Brazilian Portuguese. Fees associated to International Inspections are charged by ANVISA. Once obtained, the registration remains valid for 5 years.

Q. Is there a pre-market notification process (PMN) in Brazil?

A. Brazil does not have any policy for pre-market notification process like the FDA 510(k). The company must get the registration approval before launching its product in the market. No product can be advertised or sold without listing or registration.

Q. We have done some registrations already with a local distributor in Brazil, but they are not performing well. Can we transfer those registrations to another firm?

A. As per Resolution RDC nº 246 of September 4, 2002, based on Decree 3.961/01, the transfer of a product registration from an original owner (agent, distributor or local subsidiary of an international company) to a different company will not be allowed. This can be done only if the transferring company proves the following has occurred: dissolution of partnership; incorporation of one company by another; joint venture; inheritance and change of the company's name (Art. 23, VII). However, please, consider the advantage mentioned below.

Q. Does ANVISA require an inspection to our plant to verify our Quality Control Procedures? How long does it take?

A. ANVISA issued Resolution - RDC 25/2009 in 2009, which makes a Brazilian GMP mandatory for many products, including pharmaceuticals, equipment and device manufacturers starting on May 22, 2010. This is related to risk factors. Due to this RDC, ANVISA conducts domestic and foreign medical device manufacturers' inspections to determine compliance with Brazil's GMP regulations. A certificate is obtained on the successful completion of an audit by ANVISA inspectors, before a registration is filed. Brazil's GMP regulations resemble US FDA Quality System Regulation, known as FDA GMP. See above.

Q. What would be the advantages/disadvantages of using a local distributor?

A. An international company cannot register their products in Brazil from outside, and the papers will have to be filed by a local based company in Brazil (a Register Holder). According to the Brazilian legislation, one cannot transfer registration of products from a distributor to another, unless under certain parameters, as mentioned above. For example, let's suppose you just opt to find a distributor for your product. In this arrangement, the local distributor (or holder) will file for the registration of your products with ANVISA, but this registration will belong to this specific distributor (not to you), even if YOU paid for the registration in Brazil.

If you, for any reason want to change distributor, or even want to set up your own company in Brazil, you have to start registration all over again (and pay for it again!). See below how to use a BRH (Brazilian Registration Holder).

Q. I have decided we prefer to keep the ownership of our registration in Brazil to avoid problems with distributors. How does the process work?

This is the best alternative to enter the market, avoiding problems with distributors, and not having the high costs associated to opening your ow office.

How to Sell in Brazil Controlling Your Product Registration - Using a BRH


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The role of a Registration Holder in Brazil

The registration of products with ANVISA in Brazil, is done using the Brazilian Income Tax Number (CNPJ, in Portuguese). Obviously, to receive this number and do the registration, any international company needs to have its own CNPJ, which is possible if the company has an office or manufacturing plant in Brazil.

If the company does not have a local office or manufacturing plant, it must use a local company’s CNPJ to do the registration. This is the law. Foreign manufacturers then may opt to appoint a Brazil Registration Holder (BRH), instead of maintaining a licensed office in Brazil in order to submit product registrations with Brazilian Health Surveillance Agency (ANVISA), the entity that regulates products for health, and it is similar to FDA.

The BRH in Brazil is an entity that is responsible for the registration of products for health, and acts as a liaison between you and ANVISA. Together with the foreign products manufacturer, your company, the BRH represents (holds) the identified product registration, using its own CNPJ. Manufacturers and distributors of products for health that do not have a physical location (office or manufacturing plant) in Brazil must appoint a BRH, and maintain that BRH, for as long as they sell in Brazil.

Before selecting our company, as their independent BRH, some clients have considered appointing a distributor to fulfill this role. While it is possible to appoint a distributor located within Brazil, there are valid reasons not to appoint a distributor or sales agent for the BRH role including:

Please note: once a BRH is assigned to the device, it cannot be transferred for commercial reasons (i.e. you wish to switch distributors) and can only be transferred, for example, if two companies merge or one is spun off the other. If you select our company as the BRH, we will be identified on the registration and would fully cooperate with you so that you control the approval of your product and who can and cannot import your products.

Tasks we can perform as your BRH in Brazil

  1. Provide authorization to place our name, mailing address and phone/fax numbers on your products submissions and registrations to ANVISA;
  2. Upon request by ANVISA provide information about your product, names and addresses of distributors established in Brazil. Have access to your product documentation for inspection by ANVISA if requested. Note that we can ONLY supply this information for inspection by ANVISA upon written permission from your company and we cannot share it with any other person or entity;
  3. As the BRH, wewill request the GMP inspection, if applicable, on your behalf. We will request the inspection upon receipt of payment of the fee from your company, and in turn pay ANVISA – this is required every two years;
  4. As the BRH, wewill submit your self-inspection reports to ANVISA. Manufacturers are required to provide this in the years alternating the onsite inspections conducted by ANVISA;
  5. As the BRH, we will own the registration. We will assist distributors for the product(s) to import by providing a notarized authorization letter per shipment, to include the License of Importation number issued by ANVISA. The distributor is responsible for requesting the import number and providing it to us for inclusion in the authorization letter;
  6. We will be available to coordinate inquiries, analysis and response for reportable events as reported by users, distributors or ANVISA. We will help you determine the best response and defend your interests continually;
  7. We will do the technical representation, assistance, and reporting in case of incidents reported by users, distributors, ANVISA, including cooperation with client in coordinating and conducting Incident Reporting, and performing assessments of the severity of incidents;
  8. We will be available to act as a liaison between ANVISA and you in case of recall or risk for product withdrawal from the market;
  9. We will assist in renewal of registration of products (every 5 years).

For more information on the state of São Paulo, please, download this file.

FOR MORE INFORMATION:
J. Clovis Lemes
Candex do Brasil Ltda
Phone: (55-11) 3825-9634
Mobile: (55-11) 99206-2402
E-mail: clovis.lemes@candex.us
Website: www.candex.us
Skype: Clovis_Lemes