Brazil’s ANVISA
Medical Device/IVD
Pharmaceuticals
Cosmetics
Food Supplements
Medical Devices
GRP has a global presence with teams of local experts who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Brazil’s markets.
Medical devices are governed by ANVISA, the Agência Nacional de Vigilância Sanitária, under the Brazilian Ministry of Health. ANVISA is an autonomous arm of the government and is responsible for the protection of the public’s health.
Authorized local agent
Brazilian Health Regulatory Agency (ANVISA) requires that any Foreign medical device company, without a physical location in Brazil, who intends to sell its product in the Federative Republic of Brazil to appoint a Brazilian Registration Holder (BRH).
GRP-Brazil is licensed by ANVISA to act as your BRH.
GRP BRH Services in Brazil:
- Control your registrations and your BGMP certification.
- Communication with ANVISA
- Product Registration
- Assistance with ANVISA inspection
- Adverse Effect Reporting
- Support Importation Process
- Organize and support ANVISA consultation meetings.
- Recall or incident report assistance
- Manage Distributors
- License Renewal
ANVISA has established essential requirements for compliance similar to those developed in the European Union, and provides two major pathways to device approval: Cadastro (low risk) and Registro (high risk). Cadastro is simpler and faster, but both Cadastro and Registro require formal registration and approval from ANVISA. Some medical devices require Brazilian Good Manufacturing Practice (BGMP) certification, as well.
Global Regulatory Partners Inc. (GRP) can help you determine which of the above processes your device will fall under, as well as any additional requirements that will apply to your device. Additionally, we confirm the overall costs and timeline to market, so that you can pre-assess the requirements. GRP can assist you in evaluating the Brazilian medical device regulatory framework as it applies to your device(s).
GRP Regulatory Strategy Services in Brazil:
- ANVISA Regulatory Background
- Product Assessment based on Brazilian Requirements
- Device Classification based on ANVISA Criteria
- Additional regulations which apply to your device
- In-Country Representation in Brazil
- Registro and/or Cadastro Registration requirements
- Medical Device Labeling Requirements
- Costs and Timeframes
- Regulatory Roadmap
- Post-market Surveillance Requirements
GRP can determine the correct classification for your device, and complete all necessary documentation, to ensure a smooth registration.
- Appointing us as your Brazilian Registration Holder will allow you to maintain more control over your registrations and to add or remove distributors at any time.
- Our experienced consultants can update your existing FDA or ISO 13485 compliant quality system to meet Brazil’s Good Manufacturing Practice (GMP) requirements.
- We can assist you with INMETRO certification coordination, if necessary.
- Medical devices in Brazil are classified using a set of 18 rules found in Annex II of Brazilian RDC 185/01 published by ANVISA.
GRP regulatory affairs team has organized and supported consultation meeting with Anvisa health authorities in the medical device market. With the expertise in preparing consultation meeting with different heath authorities before starting key milestone of your product development such as GRP regulatory affairs team supports includes:
- writing
- preparation and submission of the meeting package to the ANVISA health authority
- prepare the questions to health authority based on the status of your product’s development and future plan
- provide support during the meeting
- write the meeting minutes and develop the appropriate action plan after the consultation meeting
Product registration
The first step in the Brazil regulatory process is to determine the correct classification of your medical device. Lower risk Class I and II devices will follow the Cadastro registration route, which includes a simplified application. Higher risk Class III and IV devices must follow the Registro registration process. The next step is, for all classes: you should appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH).
Medical Device Definition:
ANVISA defines medical devices as : “Health products, such as equipment, apparatus, material, item or system with a medical, dental, or laboratory use or application for prevention, diagnosis, treatment, rehabilitation and that does not use contraception and pharmacological, immunological or metabolic means to perform the main function in humans, but can be assisted in their functions by such means.”
Medical Device Regulations
- ANVISA’s overarching regulatory framework is based on Law 6360/1976, which makes provisions for health surveillance.
- The primary registration requirements are set forth in Resolutions RDC 751/2022 although a variety of guidance documents and ancillary regulations also exist.
- Resolution RDC 40/2015 governs the
- The current regulation is INMETRO Ordinance 350/2010; however, this will soon be replaced with INMETRO Ordinance 54/2016.
If your medical device is subject to IEC 60601, you likely need to obtain an additional safety certification from Brazil’s National Institute of Metrology, Standardization and Industrial Quality (INMETRO) .
INMETRO certification is conducted by a Product Certification Body or OCP (e.g., SGS, TÜV Rheinland, UL) and requires an onsite audit of the manufacturing facility – both for the
- initial certification
- annual surveillance audits.
As with device registration, INMETRO certificates require a licensed BRH. Foreign manufacturers cannot obtain INMETRO certification on their own without a local Brazilian representative. As part of the device registration, all applicable products must provide a notarized copy of their INMETRO certificates with their cadastro or registro applications.
If manufacturers have already conducted testing through an International Laboratory Accreditation Cooperation (ILAC) laboratory and if the test report is less than two years old, there is no need for INMETRO certification.
Medical Devices that use functionalities such as Bluetooth, Wi-Fi and other wireless connectivity features require ANATEL registration as per the new Brazilian medical device regulations. Recently published Technical Note 2/2018 requires ANATEL certification as a component of registration and modification applications for devices used for telecommunication as well as for devices using radio frequency (RF) or wireless technology.
Brazilian market applicants must include ANATEL certification in their ANVISA registration applications. Registrants can begin ANATEL certification before they submit their registration with ANVISA.
Table 1: Classification of medical devices in Brazil
| Device Class | Description |
|---|---|
| Class I | Lowest Risk |
| Class II | Low Risk |
| Class III | Moderate Risk |
| Class IV | High Risk |
Table 2: Regulatory Pathway for Registration
| Device Class | Description | Pathway Description | Brazilian GMP Required? | Medical Device Required Documents | Anvisa Approval Timeline |
|---|---|---|---|---|---|
| Class I and Class II Devices | Cadastro registration process | Cadastro pathway is a simplified form of registration that requires less technical data for ANVISA review. | NO | Legal Documents Technical Dossier (STED Format) Proposed RDC 185/2001-compliant labeling (IFU and Labels) to Brazilian Registration Holder (BRH) | 1- 3 months |
| Class III and Class IV Devices | Registro registration process | The registro process requires a comprehensive level of technical and clinical information provided for ANVISA review. Prior to approval of registro applications, proof of compliance with BGMP is also required. While companies may submit registro applications without proof of BGMP compliance, the application will not be approved until a BGMP certificate has been obtained for all applicable manufacturing facilities. | YES | Technical File (including): a) Preclinical Testing b) Clinical Testing Proposed Labeling and IFU as per Annex III Part B Information on your device in accordance with Annex III, Part A, B and C in RDC 185/2001 | 8-15 months |
Quality
Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. The requirements for medical devices are specified in Brazilian resolution RDC 665/2022.
In 2009, Brazil’s regulatory agency (ANVISA) issued a resolution, RDC 25/2009, that made Brazilian GMP certification mandatory for many medical device manufacturers. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for manufacturers of Class III and IV medical and IVD devices.
- Brazil has its own Good Manufacturing Practices requirements, outlined in Resolution RDC 16/2013. It is similar to ISO 13485 and US FDA current Good Manufacturing Practices.
- BGMP certification must be obtained for all applicable manufacturing sites such as design, production, assembly, labeling, and are issued to a BRH and is applicable only for Class III and/or IV medical devices.
- Foreign facilities are inspected by ANVISA (federal level) auditors, while domestic manufacturers are inspected by VISA (local level) auditors located in their state.
- MDSAP certificate would not replace the BGMP certificate , however MDSAP audit results could be used to obtain BGMP certification.
- BGMP certificates, whether issued via an onsite inspection conducted by ANVISA or by leveraging MDSAP, are valid for two years.
- Renewals must be submitted between 270 and 180 days prior to expiration
Brazil’s GMP regulations most closely resemble the internationally recognized ISO 13485 standard, and similar to Europe, ANVISA conducts inspections of medical device manufacturers to determine BGMP compliance. ANVISA will only approve device registrations after successful completion of a BGMP audit. ANVISA has supported the MDSAP program and is an active member of IMDRF. Implementation of MDSAP in Brazil can greatly reduce the burden on the manufacturers and save time and resources. With offices in Brazil and worldwide, Global Regulatory Partners has expertise with a wide range of quality management systems and can upgrade your existing QMS to comply with Brazilian GMP requirements.
Pharmaceuticals
Brazil’s Regulatory Authority:
Global Regulatory Partners, Inc. (GRP), provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in different countries at record time. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.
Through our local office in Brazil GRP can act as your local authorized agent in Brazil and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.
Pharmaceuticals in Brazil are governed by ANVISA, the Agência Nacional de Vigilância Sanitária, under the Brazilian Ministry of Health. ANVISA is an autonomous arm of the government and is responsible for the protection of the public’s health.
Authorized Local Representative
Brazilian Health Regulatory Agency (ANVISA) requires that any Foreign medical device company, without a physical location in Brazil, who intends to sell its product in the Federative Republic of Brazil to appoint a Brazilian Registration Holder (BRH). The BRH acts as a liaison between your company and Brazil’s National Health Surveillance Agency (ANVISA) and is responsible for your pharmaceutical registration in Brazil.
GRP-Brazil is licensed by ANVISA to act as your BRH.
- Control & Maintain your registrations and BGMP certification.
- Communication with ANVISA
- Product Registration
- Assistance with ANVISA inspection
- Adverse Effect Reporting
- Support Importation Process
- Organize and support ANVISA consultation meetings.
- Recall or incident report assistance
- Manage Distributors
- License Renewal
Regulatory intelligence & Strategy Services
Brazil is one of the premiere emerging pharmaceutical markets in the world, along with Russia, India and China (collectively referred to as BRIC) According to Global Data the Brazilian pharmaceutical market will expand in value from $25.3 billion in 2016 to $29.9 billion in 2021, representing a compound annual growth rate of 3.5%.
Brazilian Population:
With 25 percent of its 207 million population covered by private health plans, Brazil holds the second largest private health insurance market by population in the world. “In Brazil, the vast majority of health plans are however contracted by employers, which means that the share of the Brazilian population having access to the private health market is directly correlated to the evolution of the unemployment rate.
Brazilian Institute of Geography and Statistics estimates that the country’s senior population will surpass its young population over the next two decades, which in turn should increase the need for a wider variety of affordable medicines for age-related diseases.
Generic Drug Market:
Brazil’s market for generic drugs is witnessing rapid growth, with almost all of the country’s generics procured by the public healthcare system. Part of that dynamic stems from the Brazilian marketplace not having a generic drug presence until 1999 when the government passed its Generic Medicines Policy ( Law No. 9,787 ). Since then, generics have become the fastest growing segment of the Brazilian drug market.
- In Brazil, the prices of drugs are regulated. The Drugs Market Regulation Chamber (CMED) establishes the maximum prices applied to a drug, depending on the party in the marketing chain. The Chamber also determines the discount that the public entity should apply in order to purchase a drug. Prices of other categories of products, such as medical devices, diagnosis equipment are not regulated.
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.
Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.
Global Regulatory Partners Inc. (GRP), a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest Anvisa regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in Brazil’s markets.
GRP’s approach to designing regulatory strategy employs our strong understanding of the global markets and regulatory systems to enable our clients to make confident, actionable decisions. We specialize in assisting pharmaceutical companies with difficult and complex endeavors in LATAM. Our regulatory team in Brazil has the expertise in developing effective and tailored regulatory strategies that helped many foreign companies to register their products quickly and efficiently.
- Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.
- Proactively identify challenges or issues that may delay the approval of your pharmaceutical in Brazil.
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your pharmaceutical product registered in Brazil.
Product registration
The federal regulatory agency responsible for pharmaceutical product registration in Brazil is ANVISA (National Sanitary Vigilance agency), which was established in 1999. The 1999 Law (The Generics Law) and the ANVISA regulate the implementation of generic pharmaceuticals policy in Brazil, establishes the technical standards and defines the concepts of bioavailability, bioequivalent drugs, innovators, reference drugs, and similar. According to the Brazilian legislation, all the pharmaceutical products must be registered with ANVISA before coming to market in Brazil. Product registration in Brazil is a laborious exercise and is to be requested by the local Brazilian based office of the foreign company or its distributor in Brazil.
ANVISA classifies the products in various categories. The medications for human use are divided into three distinct areas i.e., New Product, Similar Product, Generic Product
A “biological product” is a biological that is not new or is known and contains a molecule with known biological activity that is already registered in Brazil (namely, with ANVISA) and has undergone all stages of manufacturing (namely, formulation, bottling, lyophilization, labeling, packaging, storage, quality control and release of the biological product batch for use).
- To register a new biological product or a biological product, an applicant company (applicant) must file a registration application (which must be submitted in Portuguese with one copy of the entire application being provided on a CD-ROM in a pdf format). Any documents included in a foreign language must be translated.
Active Pharmaceutical Ingredients (APIs):
- APIs Including imported ones, shall not be industrialized, exposed for sale, or commercialized in Brazil before being registered by ANVISA, except the API that will be used for scientific or technological research, as well as for research and development of formulations.
- The registration will be valid for five years and may be revalidated for equal and successive periods of time, the initial record number being maintained.
GRP product registration services in Brazil:
- Act as your local representative in Brazil.
- Confirming the classification of your Drug in Brazil .
- Comply technical file and ensure you have all the necessary documents needed for registration with Anvisa
- Translate any necessary documents into Portuguese
- Submit technical files to Anvisa
- Answer Anvisa Queries on the registration
- Maintain your License in compliance with Anvisa
Regulatory Operations
Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in Brazil and LATAM. GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements. GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements. We facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.
GRP-Brazil Regulatory operation services include:
- consulting services
- planning and assembly of submissions
- document creation and approval
- e-Submission roadmap compliance,
- publishing
- viewing and navigation
- archiving
- submission process optimization
- tracking and lifecycle management
Health Authority Consultation
In general, it is highly recommended to have a pre-consultation meeting with health authorities such as ANVISA during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
GRP regulatory affairs team has organized and supported numerous consultation meeting with ANVISA for a variety of different pharmaceutical and biologic products. GRP regulatory affairs team has the expertise in preparing consultation meeting with ANVISA heath authorities before starting key milestone of your product development.
GRP regulatory affairs team supports includes:
- writing
- preparation and submission of the meeting package to the health authority
- prepare the questions to health authority based on the status of your product’s development and future plan
- provide support during the meeting
- write the meeting minutes and develop the appropriate action plan after the consultation meeting
Clinical Trials & Services
Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is the regulatory authority responsible for review and approval of clinical trial applications for registered and unregistered drugs.
CEPs and CONEP are responsible for evaluating the ethical aspects involving human subjects and for approving the protocols when applicable. Together, the CEPs and CONEP represent the ethical review system in Brazil, known as the CEP/CONEP System.
Clinical trial application (CTA) is referred to as the Drug Clinical Development Dossier or Desenvolvimento Clínico de Medicamento (DDCM) and ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE)
- Plataforma brasil is a national and unified registry for research involving human participants.
- The platform also represents the review and approval processes of both the CEP and CONEP.
research applications can be tracked from submission to final approval by the cep, and when necessary, by CONEP. - It is mandatory for all applicants to register their clinical trials with the world health organization’s (who) ICTRP or other registry recognized by the ICMJE.
ANVISA Fees:
- A fee for the submission of the Drug Development Program
- a fee for the notification of the individual clinical trials.
Under the new regulation, Anvisa will have two new deadlines to evaluate the Drug Clinical Development Briefings (DDCM), which contain the clinical trials applications to be carried out in Brazil:
- A 90-day period for reviewing international Phase III clinical trials of synthetic medicines: if Anvisa does not reply within the 90-day period, the sponsor may start the clinical research, provided it obtains approval from the responsible ethics review boards.
- A 180-day period for reviewing local Phase I and II clinical trials: for this group of trials, the clinical research cannot begin until an official Anvisa decision.
Global Regulatory Partners clinical team apply his therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and other applicable regulatory requirements.
In an increasingly challenging environment, our clinical team has the experience and knowledge to find, recruit, and retain patients in clinical trials and successfully deliver access to appropriate sites and patients.
GRP’s clinical service for national and/or international trials includes:
- Protocol development
- Site and investigator identification and qualification
- Site initiation and training
- Clinical monitoring
- Medical monitoring
- DSMB coordination
- Statistical analysis
- Electronic data capture
- Electronic Trial Master File
- Full-service data management
- ClinicalTrials.gov registration and management
- Central lab oversight and coordination
- Site quality assurance audits
- Integrated final Clinical Study Report
Regulatory Authorities Involved in the Approval of CTA in Brazil
CTA Review Process in Brazil
QUality
National and international companies manufacturing pharmaceutical drugs, vaccines and related products in Brazil are, of course, subject to inspection by officials from ANVISA (Agência Nacional de Vigilância Sanitária, the National Health Surveillance Agency). In recent years, ANVISA inspectors have, in increasing scale, also been encountered outside of Brazil, focussing their efforts on enterprises marketing pharmaceutical products in Brazil. Such inspections are based on the Brazilian GMP guidelines the latest edition of which was published as Resolution Anvisa RDC No 17 dated 16 April 2010.
QUALITY COMPLIANCE FOR PHARMACEUTICALS IN BRAZIL:
Brazil’s GMP regulations are based on WHO GMP guidelines, and it is closely aligned to FDA and EMA GMP guidelines. Our pharmaceutical quality assurance (QA) and regulatory affairs (RA) outsourcing services include:
- Full or “as needed” consulting for ISO and/or GMP quality assurance and regulatory affairs.
- Audits of your quality management system or a supplier’s quality system.
- Review of corrective actions and recommendations for resolution.
- Supporting quality metrics and analysis as part of the management review meetings.
- Internal auditor training, risk management, quality system, or other training needs.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance of the quality system.
Cosmetics
Global Regulatory Partners Inc., affiliate in Brazil (GRP-Brazil) is authorized by Anvisa and can help your company find the right regulatory pathway for your cosmetics in Brazil. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in Brazil and find the appropriate local distributor for your product.
In Brazil, Cosmetics are regulated by the Brazilian Health Regulatory Agency (Anvisa) under Resolution RDC 752/2022 related to personal hygiene products, cosmetics and fragrances market authorization in Brazil. Foreign manufacturers that want to import cosmetics products into Brazil need to assign an Authorized Local Agent who will handle their products’ registration in the country.
GRP Inc. has local offices in the Brazil and is licensed by the Anvisa to act as your authorized local representative. GRP Inc. can act as your local agent in Brazil for your cosmetic and Personal Care Products. GRP Inc. can make sure your cosmetics and PCP comply under Resolution RDC 7/2015 that was amended by Resolution RDC 237/2018.
GRP Brazil Cosmetic Services:
- Authorized local Agent
- Regulatory intelligence
- Regulatory Strategy
- Regulatory affairs
- Product Registration
- Cosmetic packaging and labeling review
- Product classification & Formulation Review
GRP RI Services:
Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. GRP experts can collect the regulatory and other important requirements applicable to your product such as:
- registration dossier,
- claims,
- prohibited list of ingredients,
- specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in a market.
Global regulatory Partners, Inc., provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with local and /or regional requirements and the products can be used safely by consumers. GRP Inc. can review your products and make sure they comply with:
- RDC 07/2015: Technical requirements for the regularization of personal care products, cosmetics and perfumes.
- RDC 237/2018: Changes some topics of the RDC 07/2015 and RDC 15/2015.
In Brazil, Cosmetics are part of a category of products involving Personal Care Products, Cosmetics and Perfumes and cosmetics are divided into two categories, class I and class II.
Class I : are personal care products, cosmetics and perfumes whose formulation complies with the definition, and are characterized by having basic or elementary properties, whose proof is not initially necessary and do not require detailed information regarding their mode of use and their restrictions of use, due to the intrinsic characteristics of the product.
Class II: are personal care products, cosmetics and perfumes whose formulation complies with the definition, and which have specific indications, whose characteristics require proof of safety and/or efficacy, as well as information and care, mode and restrictions of use.
Product Notification VS. Product Registration
Notification of cosmetic products are product that are exempt from registration. These product are usually class I products and the local representative must submit a “prior communication” to Anvisa via a an online portal that informs Anvisa of an intent to commercialize in the country.
The registration of a cosmetic product is a longer process because the product must submit a list of required documents proving that the product is safe and effective, hence Class II products. Once the applicant receives a sanitary license and the product has been published in the Official Journal of the union (DOU) the product is allowed to be imported and commercialized in Brazil.
GRP Product Review and Registration Services:
- The analysis of the list of cosmetic and PCP ingredients,
- The review of their formulation and labeling.
- The overall review of products to make sure they comply with Anvisa’s and Mercursor Resolution.
Download our Whitepaper for a summary on how Cosmetics are classified, registered and notified with Brazil’s Anvisa
Food Supplements
Global Regulatory Partners, Inc. (GRP), has a team of experts in Brazil who can help Nutraceutical and food supplements companies in Brazil during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.
Local Representation & Regulatory Affairs
Definition:
“Product for oral administration, presented under pharmaceutical dosage forms intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, alone or in combination.”
Dietary Supplements Include:
- Vitamin and mineral supplements;
- Bioactive substances and probiotics;
- Novel foods;
- Foods with claims of functional properties;
- Athlete supplements
- Supplements for pregnant women and nursing mothers;
- Specific non-prescription medicines.
FOODS AND PACKAGES THAT REQUIRE SANITARY REGISTRATION:
- Supplements containing enzymes or probiotics
- Supplements with functional and/or health claims
- Children’s food
- Formulas for enteral nutrition
- New technology packaging (recycled)
- New foods and new ingredients
Labeling Requirements:
The labeling of food supplements shall have the following information:
I. The recommendation for use according to population group and age range in the case of children;
II. The quantity and frequency of consumption for each of the population groups indicated on the label;
III. Highlight and bold warning:
- Example: “This product is not a medicine”
- The instructions for storage, including after opening the package.
Claim Compliance:
The claims authorized for use in food supplements are established in Anvisa Regulations.
The labeling of food supplements may not present words, brands, images or any other graphic representation, including in other languages, which state, suggest or imply, expressly or implicitly, that:
- The product has a medicinal or therapeutic purpose;
- The product contains unauthorized or prohibited substances;
- The food is not capable of providing the components necessary for health; or
- The product is comparable or superior to conventional foods.
Language
When the label is not in Portuguese, an additional tag or cover label should be placed, containing the mandatory information in Portuguese with appropriate size, highlight and visibility characters. This label can be placed in the country of origin or destination. In both cases, the application must be made before commercialization.
Nutritional Information:
The nutritional information shall contain:
- The quantities of all nutrients, bioactive substances, enzymes and probiotics provided by the product;
- The percentage daily value (%VD) should be declared for each of the specific population groups indicated on the label, based on the recommended daily intake values.
- Review of Label compliance according to regulations
- Review of Leaflets
- Translation of labels
- Verification of health claims
- Review of substances in product including ( allowed max/min dose and status according to regulations)
- Brazilian Registration Holder (BRH)
- Review of Label compliance according to regulations
- Formula Review & Compliance
- Product Registration
- Importation
- Customs Release
- Warehousing & Distribution
Brazil Anvisa Food Supplement Regulations
GRP RI Platform has formatted and translated (English) regulations for Food Supplements. Other Regulations for Cosmetics, Medical Device, Drugs, Clinical Trials are also available.