Founded in Canada, Candex is formed by a team of consultants with proven experience in international business and diplomacy. The founder of the company is a former U.S. Department of Commerce Business Development Specialist, who received four Honor Awards for Innovation and Business Excellence. He was also a Commercial Officer of the Canadian Trade Commission in Brazil, with wide experience in business in North and South America, focused in high technologies. One of our major accomplishments has been assisting the Brazilian Government (Ministry of Health) in studying the U.S. health/regulatory system to form ANVISA - Brazilian Health Vigilance Agency, a FDA-like agency.
Brazil ANVISA electronic submission of medical device import petitions becomes electronic. According 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:
Changes related to filing documents with ANVISA:
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), which is basicall every product unders ANVISA's vigilance, 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 of the Sanitary Law 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 Representatives 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.
Product registration receipt 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 is required from the cosmetics, vitamin, and pharmaceutical manufacturers:
There are two types of regularization of products with 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:
“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 Resolution - RDC 207, of November 17, 2006. As for listing, the applicable legislation is Anvisa’s Resolution Normative Insttruction 7 of June 7, 2010 that lists medical equipment and materials used for health that do not fit the registration situation, remaining in the obligation to register with ANVISA.
Electrical/electronic medical devices manufacturers must apply for product registration not only with ANVISA. For medical devices falling under the scope of IEC 60601-1 and for some other non-active medical devices, as found in this link, must be in conformity with guidelines of 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.
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.
Note: for Vitamines, please see below "The Case of Vitamines", under the Food Secction
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 97, of August 1, 2016.
(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 as a product resulting from:
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:
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).
Classified according to the health risk they may present, hence the need to register (or exempt) certain products.
The Resolution for registration of personal care products, cosmetics and Perfumes, or registration changes has been updated by resolution RDC No. 237, of July 16, 2018. Paragraph 2. Manufacturers and importers of personal hygiene products, cosmetics and perfumes may require regularization, revalidation, renewal or alteration of their products based on this Resolution, without prejudice to the need to comply with the date mentioned in the caput.
Article 1 Annex VIII of the Resolution of the Collegiate Board of Directors - RDC No. 7 of February 10, 2015, which establishes which personal hygiene products, cosmetics and perfumes are subject to registration for commercialization, shall be in force with the following wording:
Annex VIII Grade 2 Products subject to Registration:
RDC No. 250, of November 21, 2018 provides for the requirements for the presentation of Labeling design or Labeling in the process of regularization of personal hygiene products, cosmetics and perfumes, and for the coexistence of more than one design for the same product. This is the link to the RDC (in Portuguese). If you need translations of RDC's, please contact us.
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.
4. Food (including beverages, bottled waters, food additives).
The products that DO NOT REQUIRE registration with either ANVISA or the Ministry of Agriculture are listed on RDC - Resolution 27 of August/6/2010. If you require a translated listing, contact us.
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).
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 in Brazil following some strict guidelines:
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.
These are the norms associated with Food Supplements:
Need translations? Please contact us.
The case of plant-based products - a.k.a. phyto-products: Products Regularization - Medications - Phytotherapy Guidelines. Anvisa has debated for a long time how to deal with phyto-products, and has set up a series of guidelines specific to this topic:
Registration timeline: 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).
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's technician’s interpretations, (who may or may 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. The pertinent legislation is here: RDC No. 59/2010 - Provides for the procedures and technical requirements for the notification and registration of sanitizing products and makes other provisions; RDC No. 32/2013 - Provides for the procedures and technical requirements for the registration of sanitizing products that are corrosive to the skin or that cause serious eye injury and provides other measures.
Note on OTCs: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. According to Resolution - RDC 98/2016 for OTC's (Over the Counter Products) prescription-exempt products are those medicines which can be dispensed without a requirement of prescription, that is, the medicines available to self-service in pharmacies and drugstores that do not require medical prescription for dispensing. The packaging of the MIPs (as they are called in Brazil) does not have warning stripes like those of prescription drugs (red stripe) or subject to special control (black stripe).
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.
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