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).This company 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 GlobalData t he Brazilian pharmaceutical market will expand in value from 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 subsidises 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 t