Brazil
Brazil
ANVISA Registration
The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices. In Brazil, the production, import, storage, transportation and sale of these products are required to obtain the qualification certificate issued by ANVISA. ANVISA collaborates with customs and airports to approve the import and export of medicines, biological products, and biological samples.
ATIC provides one-stop ANVISA certification services including testing, technical review, legal representative, application and registration etc.
ATIC provides one-stop ANVISA certification services including testing, technical review, legal representative, application and registration etc.
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ANVISA Registration of Various Products in Brazil
Medical Device ANVISA Registration
Introduction
ANVISA classifies medical devices into 4 categories according to the hazard level, which is very similar to the European Union 93/42/EEC.
- The notification process of Class I and Class II is simple, and the submitted documents are relatively simple. The registration process of Class III and Class IV is stricter. Class III and IV require factory audit and obtain GMP (Good Manufacturing and Control Practices) certificate.
- Some medical products, such as electronic medical devices, needles, and breast fillers are under the jurisdiction of two departments in Brazil: INMETRO and ANVISA. INMETRO certification is required before ANVISA registration.
- Class I and Class II products are always valid after registration. The ANVISA registration of III and IV products is valid for 10 years. The update process can be started in the first half of the year before expiration. If you want to suspend the certificate out of personal wishes, you need to apply to ANVISA specifically. ANVISA will supervise products and receive market complaints.
Certification Process
Documents Required
- Name and address of manufacturer and importer
- Medical product identification information
- Authorization Letter
- Technical documentation
- Manufacturing local registration certificate or free trade certificate
- Other documents required by ANVISA
Label Information
- Portuguese label
- Instructions for use
- Necessary information for safe and correct use of the product
- Serial number, ANVISA number
- Other special statement
Technical Documents
- Product details
- Use
- Precautions for storage and transportation, restrictions, warnings, special attention and clarification
- Usage
- Production flow chart
- Describe the effectiveness and safety of medical products according to the basic requirements of ANVISA regulations
- The company’s legal and technical managers are responsible for the information provided in this technical report and must post their name, position or professional registration and signature
Drug ANVISA Registration Introduction
- According to the Brazilian Pharmacopoeia, drugs sold in Brazil need to meet the relevant requirements of the Pharmacopoeia. The drugs in the Pharmacopoeia include: medical supplies, medical plants, biological products, blood components and blood products, radiopharmaceutical and medical gases, etc.
- For some over-the-counter medicines with lower risk, registration can be carried out only through simplified notification procedures, but registration still requires the GMP certificate of the ANVISA method and information such as importers, and documents need to be submitted.
Expiration Date
- Generally valid for 10 years
- For drugs that have been registered with the agreement of the commitment, the initial registration is valid for 3 years, 5 years after the first renewal, and 10 years after the second renewal.
- Remarks: If there is a special declaration, some drugs can be exempted from registration.
Disinfection Product ANVISA Registration Introduction
Disinfection products such as algaecide, bleach, drinking water disinfectant, deodorant, mosquito repellent, rodenticide, detergent and other disinfection products for swimming pools sold in Brazil need to be registered. According to the requirements of ANVISA, the Brazilian National Sanitary Surveillance Agency, disinfection products can be classified into two categories, namely Risk Product 1 and Risk Product 2. Risk 1 products can only be sold after being notified via a full electronic petition and posted on the ANVISA website and on the Internet. Risk Product 2 can only be sold after obtaining the registration published in the Federal Official Gazette (DOU, Diário Oficial da União).
Disinfection of Product Classification
Risk Product 1:
- For liquid products, the oral LD50 of rats is greater than 2000mg/kg, and for solid products, the oral LD50 is greater than 500mg/kg
- At a temperature of 25 degrees Celsius, the pH value is greater than 2 and less than 11.5
- Not corrosive, antimicrobial activity, bactericidal effect, nor based on living microorganisms
- The formula does not contain one of the following inorganic acids: hydrofluoric acid (HF); nitric acid (HNO3); sulfuric acid (H2SO4) and salts that release them under product use conditions
Risk Product 2: Other products
Product Classification
ANVISA supervises cosmetics and personal hygiene products sold in Brazil. According to the product's formula, purpose of use, parts of the body and possible risks, cosmetics and personal hygiene products are divided into 2 class. Class 1 products are safer. There is no need to register or submit information or prove security. Class 2 requires registration, requires proof of safety and/or efficacy, and restrictions on methods of use.
- Examples of Class 1 products: perfume, lip gloss, cleansing oil, mouthwash, wet wipes, shower gel, shampoo, etc.
- Examples of Class 2 products: children's cosmetics, hair dyes, anti-dandruff/anti-shampoo shampoos, antibacterial gels for hands, etc.
Expiration Date
- Class 2 products are required to be registered, and other products do not need to be registered, but need to perform the advance notification procedure and report to ANVISA.
- The ANVISA registration is valid for 10 years, and the recertification process can be initiated in the first half of the year before expiration.
- ANVISA is mainly to supervise the effectiveness of such products and prohibited substances, including: preservatives, colorants, prohibited substances, UV protection substances, etc.
Food ANVISA Registration Introduction
In Brazil, the following categories of food must be hygienic registered: food for vulnerable groups, including infants and enteral formula; foods with functional or health claims; new foods; products using new technologies, including desalination and recycling packaging; And food supplements containing probiotics and enzymes.
ANVISA Registration Scheme
- Register on the ANVISA official website
- Simplified registration: registration at the Brazilian Local Health Supervision Office
- Some foods are exempt from registration
Registration-Free Products
This model is applicable to raw materials, food additives and technical adjuvants that are exempt from registration according to their specific technical regulations, as well as food raw materials for industrial use. The types of exempted food registration are stipulated in University Council Resolution 27/2010.
Pesticide ANVISA registration Introduction
In Brazil, the conformity of pesticides is regulated by ANVISA and the Ministry of Environmental Protection IBAMA. Organic pesticides need to be registered in ANVISA. The pesticides that need to be registered can be divided into 3 class:
- Microbial control agent
- Biological control agent
- Semi-chemical
For biological products that do not fall into the above categories, legislation on the registration of general pesticides for biological products that do not fall into one of the above categories will be required (Law No. 4.074/2002, RDC No. 216/2006 and Law No. 03/1992) All requirements and studies contained.
Pesticide Classification
ANVISA mainly limits the pesticide residues in fruits and vegetables. Pesticides need to be toxicologically evaluated, indicate their content, and calculate the acceptable intake. ANVISA divides pesticides into 4 class according to their toxicology categories:
- Class I：Severely toxic products
- Class II：Highly toxic products
- Class III：Poisoned products
- Class IV：Low toxicity products
Tobacco ANVISA registration Introduction
Before industrialization and commercialization, national tobacco manufacturers, exporters and importers must: have the Administrative Declaration Act (ADE) issued by the Brazilian Federal Taxation Agency (SRF/MF) granting a special register of manufacturers or importers (only applicable for cigars and cigarettes); and products in the ANVISA register. According to regulations RDC46/2016, Brazil bans the sale of electronic cigarettes and allows the sale of cigarettes and cigars and other tobacco products.
Registration Requirements
The test report seeks to provide tobacco with nicotine, carbon monoxide, formaldehyde, acetaldehyde, acetone and other nearly 50 compounds. The experimental analysis must be conducted in a laboratory accredited by Brazil or an international accreditation body, and must follow internationally recognized analytical methods, and only accept test reports (generally ISO standards) that are drawn up to six months before the date of application.
Expiration Date
Tobacco product registration is valid for one year and needs to be updated every year. When updating, re-submit petitions, technical documents, packaging drawings and test reports. Packaging materials, filtration technology, and product names cannot be changed during the renewal. If any changes are deemed as new products, you need to re-register.
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ANVISA Requirements
| No. | Items (Portuguese) | Items (English) | Standards |
| 1 | Define os requisitos de notificação e cadastro de produtos médicos | Defines notification requirements and registration of medical products |
RDC No.40, OF AUGUST 26, 2015
|
| 2 | Aprovar o Regulamento Técnico que consta no anexo desta Resolução, que trata do registro, alteração, revalidação e cancelamento do registro de produtos médicos na Agência Nacional de Vigilância Sanitária - ANVISA |
Approve the Technical Regulation contained in the annex to this Resolution, which deals with the registration, alteration, revalidation and cancellation of the registration of medical products at the National Health Surveillance Agency - ANVISA |
DRC No.185, OF OCTOBER 22, 2001
|
| 3 | Dispõe sobre os requisitos técnicos para a regularização de produtos de higiene pessoal, cosméticos e perfumes e dá outras providências |
Provides for technical requirements for the regularization of personal hygiene products, cosmetics and perfumes and other measures |
RDC No.7, OF FEBRUARY 10, 2015 |
| 4 | Dispõe sobre a classificação de risco, os regimes de controle de notificação, cadastro e registro e os requisitos de rotulagem e instruções de uso de produtos para diagnóstico in vitro, inclusive seus instrumentos e dá outras providências |
Provides for risk classification, notification, registration and registration control regimes and labeling requirements and instructions for the use of in vitro diagnostic products, including their instruments and other measures. |
RDC No.36, OF AUGUST 26, 2015 |
| 5 | Dispõe sobre os procedimentos e requisitos técnicos para a notificação e o registro de produtos saneantes e dá outras providências | Provides for technical procedures and requirements for the notification and registration of sanitizing products and provides other measures | RDC No.59, OF DECEMBER 17, 2010 |
| 6 | Dispõe sobre o registro de produtos fumígenos derivados do tabaco | Provides for the registration of smoking products derived from tobacco | RDC No.226, OF APRIL 30, 2018 |
| 7 | Define os critérios cronológicos para análise dos processos de registro ou cadastro de produtos definidos como Produtos Para Saúde, no âmbito da Agência Nacional de Vigilância Sanitária | Defines the chronological criteria for analyzing the registration or registration processes of products defined as Products For Health, within the scope of the National Health Surveillance | DRC No.3, OF 2 FEBRUARY 2010 |
| 8 | Aprova o Regulamento Técnico de Boas Práticas de Fabricação de Produtos Médicos e Produtos para Diagnóstico de Uso In Vitro e dá outras providências | Approves the Technical Regulation of Good Manufacturing Practices for Medical Products and Products for Diagnosis of In Vitro Use and provides other measures | RDC No.16, OF MARCH 28, 2013 |
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