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.
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.
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.”
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).
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%.
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.
New opportunities for foreign manufacturers include:
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.
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).
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.
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
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).
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.”
| Device Class | Description |
|---|---|
| Class I | Lowest Risk |
| Class II | Low Risk |
| Class III | Moderate Risk |
| Class IV | High Risk |
| Device Class | Description |
|---|---|
| Class I and Class II Devices | Cadastro registration process |
| Class III and Class IV Devices | Registro registration process |
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:
Class I and II registrations do not expire.
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.
| 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 |
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
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.
| Device Class | Approval Time |
|---|---|
| Class I | 1-3 months |
| Class II | 1-3 months |
| 8-15 months | Moderate Risk |
| Class IV | 8-15 months |
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.
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 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:
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.
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 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.
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.
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:
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.
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%.
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.
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.
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
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.
Taxes and Regulatory hurdles have been the two major deterrents for investment in the Brazilian pharmaceutical industry.
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.
Brazil’s tax code is highly convoluted, the code levies greater import taxes on pharmaceuticals than on any other goods.
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.
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.
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
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.
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.
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.
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)
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:
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.
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.
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:
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.
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 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”.
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.
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.
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.
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.
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
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:
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.
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:
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
In developing the regulatory strategy, our team takes into consideration different factors such as:
Global regulatory Partner, Inc. provides a full regulatory affairs service from product concept throughout product development till product registration.
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:
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.
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 : 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.
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.
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.
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.
“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.”
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
