Brazil- Anvisa

Medical Devices

Brazil’s Regulatory Authority:

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.

Anvisa Regulatory Framework:

  • ANVISA’s overarching regulatory framework is based on Law 6360/1976, which makes provisions for health surveillance
  • Decree 8077/2013, which regulates the registration, control, and monitoring of the products addressed by Law 6360/1976.
  • Decree 8077/20136 outlines the operating conditions for companies such as manufacturers, distributors, and importers subject to licensing within the scope of health surveillance in Brazil.

anvisa Medical Device Definition:

ANVISA defines a medical device in Annex I, section 13, of Resolution 185/2001:

“Medical Device: Health product, 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 its functions by such means.

GRP Medical Devices Services:

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.

More Resources:

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 Local Agent 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 Regulation. Blog. Medical Device. RDC 305/2019
Brazil- Anvisa

Regulatory intelligence

Brazil is the largest economy in Latin America, and the largest medical device market. It was valued at US$4.7 billion in 2015 but projected growth is very slow due to Brazil’s mounting recession. The market will contract in coming years with an overall value increase to US $5.5 billion by 2020.In general, the segmentation of the market for medical equipment and devices is: Reagents for In Vitro Diagnostic at 20%; Materials and Consumables at 19%; Prosthesis, Implants and Parts at 15%; Lab equipment at 14%; Imaging equipment and consumable at 8%; Dental Equipment at 3%; Furniture at 2%; Other at 19%. 

Regulatory Authorities: 

Medical devices in Brazil are regulated by the National Health Surveillance Agency (“ANVISA”) and by the National Institute of Metrology Standardization and Industrial Quality (“INMETRO”), both issuing mandatory regulations to which medical devices companies must comply as well as voluntary product standards. Electromedical devices must additionally be certified by INMETRO to obtain ANVISA registration. 

Medical Device Market Trends:

New opportunities for foreign manufacturers include:

  • Clinical Chemistry, Biomedical, and advanced medical devices – High demand for new technologies;
  • Laboratory equipment – Investments in R&D, including some duties and registration exemptions;
  • Disposables and surgical – High consumption by private and public hospitals;
  • Diagnostic devices and monitoring equipment – High demand for innovative products
  • Orthopedics and Implants – High demand of imported products, despite higher sanitary requirements;
  • Health IT – Demand in hospitals, including education, telemedicine, big data and integration systems;
  • Dental – Brazil has one of the highest numbers of dentists in the world;

GRP RI Services in Brazil:

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.

At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Brazil.

Regulatory Strategy

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

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

GRP Regulatory Affairs’ Services:

Global regulatory Partner, Inc. (GRP), provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include

  • regulatory intelligence
  • regulatory strategy
  • regulatory operations
  • and publishing; product registration
  • registration amendments
  • consulting meetings with regulatory authorities
Regulatory Affairs | Global Regulatory Partners

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
  • Decree 8077/2013, which regulates the registration, control, and monitoring of the products addressed by Law 6360/1976.
  • Decree 8077/20136 outlines the operating conditions for companies such as manufacturers, distributors, and importers subject to licensing within the scope of health surveillance in Brazil.
  • The primary registration requirements are set forth in Resolutions RDC 185/2001 and RDC 40/2015, 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.

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
Class I and Class II Devices Cadastro registration process
Class III and Class IV Devices Registro registration process

Cadastro Pathway:

Cadastoro Pathway is applicable to all Class I and II medical devices.

Cadastro pathway is a simplified form of registration that requires less technical data for ANVISA review.

The applications includes the following document:

  • Application form based on the type of product (e.g., material, equipment, software),
  • Letter of Authorization from the foreign manufacturer to local  representative in Brazil
  • Any additional Brazilian certifications required for that product.

Class I and II registrations do not expire.

Registro Pathway

Registro Pathway is applicable to all Class III and IV devices.

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.

Once approved, Class III and IV registrations are valid for ten years.

Renewal applications must be submitted at least 180 days (six months) prior to the expiration date.

Table 3: Medical Device Required Documents

Device Class Description of Requirements
Class I and Class II Devices Legal Documents Technical Dossier (STED Format) Proposed RDC 185/2001-compliant labeling (IFU and Labels) to BRH
Class III and Class IV Devices 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

INMETRO Certification:

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.

ANATEL 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 4: Registration Timelines

Device Class Approval Time
Class I 1-3 months
Class II 1-3 months
8-15 months Moderate Risk
Class IV 8-15 months

GRP Product Registration Services:

  • We 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.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise ANVISA health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc. (GRP) , has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Medical writing | Global Regulatory Partners

Health authority consultation

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 Consultation Services in Brazil:

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

 

meeting | health authority
Brazil- Anvisa

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 16/2013.

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.

 

quality, inspection, audit

Anvisa GMP Inspection:

  • 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

QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES IN BRAZIL

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.

GRP Brazil Quality Services:

  • We can modify your existing QMS to meet Brazil’s GMP requirement.
  • Our in-depth knowledge of the Brazilian regulations ensures that your quality systems will be up to date.
  • We have experience assisting hundreds of manufacturers with BGMP compliance, ANVISA registration and other regulatory consulting services.

Pharmaceuticals

Brazil’s Regulatory Authority:

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.

Biologics in Brazil:

The Anvisa standard that provides for the registration of biological products is RDC No. 55/2010

The registration of biological products are defined as drugs that have, as their active ingredient:

  • (i) molecules extracted directly from microorganisms, organs, or tissues of animal origin, or cells or fluids of human or animal origin (“biological origin”) or
  • (ii) molecules produced by the process of genetic modification (“biotechnological origin”).

GRP Pharmaceutical Services:

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.

More Resources:

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). 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.

GRP Pharmaceutical 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 Regulation. Blog. Medical Device. RDC 305/2019
Brazil- Anvisa

Regulatory intelligence

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.

Biologic Market:

 Brazil’s Ministry of Health subsidizes the use of biological products through numerous programs. While biological products represent only 2% of all drugs distributed by the government, they represent 41% of the total spent annually by the Ministry of Health on medicines. Among biological products the monoclonal antibodies are the most significant, as despite representing only 1% of all biological products 

Reimbursement:

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.

GRP RI Services in Brazil:

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.

Regulatory Strategy

Obstacles to Market:

Taxes and Regulatory hurdles have been the two major  deterrents for investment in the Brazilian pharmaceutical industry.

Bureaucracy:

Brazil is notorious for its bureaucracy system. An arm of ANVISA , The Drugs Market Regulation Chamber (CMED), tightly regulates price on medicines. Each year, CMED sets a maximum price increase that drugmakers have to follow; it also plays a prominent role in the complex and quite secretive process of formulating a treatment’s price tag. Prices of other categories of products, such as medical devices, diagnosis equipment are not regulated.

Brazilian Tax code:

Brazil’s tax code is  highly convoluted, the code levies greater import taxes on pharmaceuticals than on any other goods. 

GRP’s Pharmaceutical Regulatory Strategy Services in Brazil:

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.

Regulatory Affairs

Regulatory Affairs | Global Regulatory Partners

Global Regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP Inc. regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

GRP regulatory affairs services include:

  • regulatory intelligence
  • regulatory strategy
  • regulatory operations and publishing
  • product’s registration
  • products’ life cycle management and maintenance

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

Drug Registration Pathways

Biologics/Biosimilars:

  • 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.

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.

Global Regulatory Partners Inc. (GRP) 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

Medical writing

Medical writing | Global Regulatory Partners

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

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 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.  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.

Clinical

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)

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)

Regulatory Authorities Involved in the Approval of CTA in Brazil

CTA Review Process in Brazil

Clinical Trial Registry in Brazil:

  • 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.

Clinical Trial Regulations:

ANVISA Fees:

  • A fee for the submission of the Drug Development Program
  • a fee for the notification of the individual clinical trials.

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

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, inspection, audit

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

Cosmetic Regulations in Brazil:

In Brazil, Cosmetics  are regulated by the Brazilian Health Regulatory Agency (Anvisa) under Resolution RDC 7/2015 that was amended by Resolution RDC 237/2018 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.

Anvisa Cosmetic Definition:

In Brazil, Cosmetics are defined as products “Used in the  preparations of natural or synthetic substances, for external use on diverse parts of the human body, skin, hair, nails, lips, external genital organs, teeth, and mucous membranes of the oral cavity, with the sole or main objective of cleaning them, perfume them, alter their appearance and/or correct body odors, and protect and maintain them in good condition.

Anvisa Cosmetic Categories:

Anvisa classifies cosmetics in two categories, Grade I and  Grade II based on their risk to users.

Cosmetic Registration Pathways:

There are two ways for Cosmetics to be authorized into the Brazilian Market: Pre-market Approval Registration or Advanced Notification. Products listed in Annex VIII are subject to the pre-market approval procedures and products that are not are exempt from pre-market approval and are only subject to a notification procedure. 

GRP Services:

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.

More Resources:

  • Read More’- To access more information on Cosmetics and GRP’s services in Brazil.

Brazil Regulatory Cosmetic Authorities:

ANVISA:

promote the protection of the health of the population through the sanitary control of the production and consumption of products and services subject to sanitary surveillance, including the environments, processes, inputs and technologies related to them.

GHCOS:

Coordinates, supervises, and controls the activities related to the registration, information, inspection, norms and standards establishments, compliance with regulations concerning the sanitary surveillance of personal care products, cosmetics, perfumes and sanitizers.

Authorized local agent

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
Brazil- Anvisa

Regulatory intelligence

Brazil  Cosmetic Market Overview:

With more than 209 million inhabitants. Brazil is the largest and most populous country in South America. It is estimated that the beauty industry in Brazil nearly accounts for 20% of Brazil’s GDP and believed to grow by 57.6 % bring out USD 600 billion in revenue with CAGR of 6.57% between 2020-2025.

The overall market is segmented by:

Personal Care Products which includes Hair Care Products, Facial Care Products, Shower Gels, Oral Care, Men’s Grooming Products, and Deodorants and Antiperspirants;

Cosmetics/Make-up Products including Facial Cosmetics, Eye Cosmetic Products, Lip and Nail Make-up Products, Hair styling and coloring products;

Distribution Channel via Specialist Retail Stores, Supermarkets/Hypermarkets, Convenience Stores, Pharmacies/Drug Stores, Online Retail Channels, Others;

Category of Mass Products and Premium Products

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.

Regulatory Strategy

Developing the right regulatory strategy for your products for different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets. 

COMPANY SUCCESS POINTERS

While entering a new market, a company should thoroughly study about the theme and essence of the country. What governs a successful launch is when the indigenous of a country is maintained with a tint of modernization. Our research has shown that Brazilians strongly believe in following and for a company to launch their brands needs to take into account:

GRP Regulatory Strategy Services:

In developing the regulatory strategy, our team takes into consideration different factors such as:

  • information on your products and similar products on the market
  • your product development status and milestones,
  • your business goals and timelines,
  • the regulatory requirements related to your product
  • cost
  • risk assessment

GEOGRAPHICAL AND ETHNIC DIVERSITY

  • Companies seeking to design cosmetics and personal care products for the Brazilian market must understand the regional ethnic diversity. This thoroughly governs the product range that will be required to take into consideration the plethora of different skin and hair needs.
  • Brazil is divided geographically into five regions well-defined by unique ethnic complexities as well as different cultural and climatic conditions.

MARKETING AND SALES

  • The country has a vast network of distributors, in order to place well one needs to offering a wide range of products at attractive price.
  • The company needs to work on effective strategies to build a strong brand awareness and generate traffic.
  • They should have a reliable supply chain for quick turnarounds and investing heavily in state-of-the-art technologies to provide constant innovation and new product offerings.

ECO-CONSCIOUS

  • While Brazilians’ strong affinity to beauty products is well-known, that foreign brands have difficulty in grasping is that Brazilians are extremely eco-conscious. More than half of Brazilian consumers consider the environmental impact of cosmetics and skincare when purchasing any products, the highest for any country.
  • They associate beauty with sustainability. In 2018 a survey founded that 82% of Brazilian women they prefer products containing natural ingredients than their chemical counterparts and are willing to spend more for such natural products

FORMULATION

  • Brazilians believe that their local ingredients have strong cultural value and hence they look out for products formulations with indigenous ingredients

Regulatory Affairs

GRP regulatory affairs services include:

Global regulatory Partner, Inc. provides a full regulatory affairs service from product concept throughout product development till product registration.

  • regulatory intelligence
  •  regulatory strategy, 
  • Product Classification
  • formula, labeling and packaging review
  • product registration,
  • registration amendments
Regulatory Affairs | Global Regulatory Partners

Cosmetic packaging and labeling review

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.

Product classification & Formulation Review

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. 

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. 

Class I Cosmetics and Products:

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 Cosmetics and Products:

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. 

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. 

Nutraceuticals

GRP Nutraceutical Services:

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.

More Resources:

  • Read More’- To access more information on Nutraceuticals/ Dietary Supplements and GRP’s services in Brazil.
  • GRP Presentation- Overview of Dietary Supplement Registration in Brazil.

Regulatory authority

ANVISA:

Coordinates, supervises, and controls the activities related to the registration, information, inspection, norms and standards establishments, compliance with regulations concerning the sanitary surveillance of food, water, beverages and their ingredients.

GGALI:

Provides supplementary assistance to state and municipal health surveillance agencies in the development and implementation of health inspection and risk monitoring programs; and food legislation.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, product registration, product formulation and labelling review.

GRP  team provides support to Nutraceutical companies during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers, reviews and validates the nutrient content claims and health claims before products’ commercialization.

Regulatory Affairs | Global Regulatory Partners

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:

  1. Vitamin and mineral supplements;
  2. Bioactive substances and probiotics;
  3. Novel foods;
  4.  Foods with claims of functional properties;
  5.  Athlete supplements
  6.  Supplements for pregnant women and nursing mothers;
  7. 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

Supplement Registration Pathway  with Anvisa

Regulatory intelligence

If you want to be in Latin America, you want to be in Brazil – As one of the BRIC (Brazil, Russia, India, China) countries predicted to share increasing dominance of the world economy, expectations for Brazil’s economic growth have been high. Prior to  2018 dietary supplements had no legal definitions. In recent years, ANVISA has finally introduced ANVISA RDC No. 243/2018, which defines the sanitary requirements for dietary supplements and is characterized as a regulatory framework in Brazil.

From 2010 to 2016, the consumption of dietary supplements in Brazil increased 233%, reaching a turnover of 1.49 billion reais .  According to Euromonitor, the over-60 market is going to contribute about 13 percent of Brazil’s total income.  Supplements have been trending as best sellers in the past 10 years include calcium supplements (bone health), anti-aging products, such as Ginkgo biloba,  fish oils (DHA) , and beauty foods fortified with antioxidants such as vitamins C and E.

GRP RI Services:

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.

At Global Regulatory Partners Inc. (GRP) , a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Nutraceuticals in different markets.

Verification of Nutrient Content Claims

Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the Regulations.

In addition, the regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement. GRP- Brazil can review your products and make sure they comply Anvisa regulation.

Nutraceuticals

Verification of Health Claims

Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. GRP’s team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements to make sure that they are supported by scientific data, are accurate and can be accepted by Anvisa standards and regulations.

Claim Compliance:

The claims authorized for use in food supplements are established in Annex V of the Normative Instruction 28/2018.

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.

Labeling

All food supplement designations must follow the requirements in Annex V or VI of the Normative Instruction n° 28/2018.

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.

Labeling Requirements:

The labeling of food supplements shall have the following information:

I.the recommendation for use according to population group(2) and age range in the case of children;

II.the quantity and frequency of consumption(2)  for each of the population groups indicated on the label;

III.highlight and bold warning: 

  • This product is not a medicine”
  • Do not exceed daily recommendation of consumption indicated on the packaging”
  • Keep out of the reach of children
  • The instructions for storage, including after opening the package.

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.

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