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Executive Summary
Brazil’s medical devices are regulated by the Brazilian National Health Surveillance Agency (ANVISA), with both ANVISA,as well as the National Institute of Metrology Standardization and Industrial Quality (INMETRO) issuing standards and guidance with which medical device companies must comply. The pharmaceutical sector faces a complex and difficult patent system, excessive bureaucracy, and strict price controls. Pharmaceutical patents are expected to be processed more quickly moving forward due to a 2021 change removing Anvisa from the process. Brazil is taking steps to remove onerous regulations for reviewing and approving clinical trials, which lowered approval time to 120 days.
Brazil is the largest medical equipment market in South America, and it is stillgrowing. Medical equipment and in vitro diagnostics revenue in 2021 reached an estimated $ 7.5 billion USD. According to the World Bank, in 2021 private and public healthcare expenses in Brazil comprised 9.1% of Brazil’s GDP.
The United States accounts for approximately 19% of the import market in Brazil, followed by China with 14% of the market and Germany with 13%. In 2021, imports of medical devices were $ 6.7 billion USD, 7.3% more than in 2020.
In general, the segmentation of the market for medical equipment and devices is:
- Reagents for In Vitro Diagnostic, 20%
- Materials and Consumables, 19%
- Prosthesis, Implants and Parts, 15%
- Lab equipment, 14%
- Imaging equipment and consumables, 8%
- Dental Equipment, 3%
- Furniture, 2%
- Other, 19%
Healthcare Policy Issues
Medical devices in Brazil are regulated by the National Health Surveillance Agency (ANVISA),as well as the National Institute of Metrology Standardization and Industrial Quality (INMETRO), both issuing mandatory regulations to which medical device companies must comply as well as voluntary product standards. Electromedical devices, hypodermic needles, breast implants, surgical gloves, and syringes must additionally be certified by INMETRO to obtain ANVISA registration. Since 2017, the Brazilian government has been exploring ways to simplify the requirements governing the manufacture, import, export, and sale of medical products, with the goal of streamlining the regulatory process. In August, 2017, ANVISA proposed extending registration validity timeframes from five to ten years, which would reduce the burden and cost of regulatory compliance for manufacturers of higher risk devices. Internationally, ANVISA has been moving towards regulatory convergence by implementing new registration procedures based on best practices from the International Medical Device Regulator Forum (“IMDRF”). Brazil has also formally implemented the Medical Device Single Audit Program (“MDSAP”) starting in January, 2017 with the intention to introduce greater regulatory flexibility and reduce the regulatory barriers for medical device approvals for foreign manufacturers operating in Brazil.
INMETRO Ordinance 54/2016, which had limited the validity period for medical device test reports to two years (four years for large medical equipment) and for certifications to five years, was amended by Ordinance 384/2020, removing the requirements for repetitive testing and re-certification. Under Ordinance 384/2020 initial and complementary test reports will be accepted no matter the date of issue, in which design changes are duly validated through retesting when there is a relevant impact on product safety related to INMETRO certification points. Certificates no longer have expiration dates and remain valid if maintenance activities are carried out and complementary testing performed when necessary, (e.g. changes that critically effect the safety of the equipment. The new ordinance also allows for the compliance identification label for medical devices to be affixed after entry into Brazil.
The pharmaceutical sector faces a complex and difficult patent system, excess bureaucracy, and strict price controls. In 2021, Brazil removed the requirement for ANVISA to initially review pharmaceutical patents prior to the National Institute of Industrial Property (INPI)reviewing them, thus improving the patent examination process for these products. However, the Government of Brazil takes an average of 11 years to grant or reject a pharmaceutical patent application. In May 2021, Brazil’s Supreme Court (STF) ruled Article 40, sole paragraph of the industrial property law, a provision which guaranteed patent protection for a minimum of 10 years from patent issuance regardless of delays in patent examination, as unconstitutional (Ref B). All future granted, including based on any patent applications pending at the time of the decisions, will now be valid for 20 years from the filing date, without a guaranteed minimum term if the examination period is longer than 10 years. As part of its ruling, the STF retroactively applied this decision to pharmaceutical and healthcare sector patents that were originally issued under the benefit of the minimum term protections. An estimate of 6,000 valid patents in the pharmaceutical and healthcare sectors subsequently had their terms revised downward, and in some cases, rendered the patents as having immediately expired. Brazil is taking steps to remove onerous requirements for reviewing and approving clinical trials, which should lower clinical trial approval times from current 15 months to 2-3 months. Over the last two years, ANVISA has made substantial progress towards eliminating the drug application backlog. Pressure to lower drug prices is expected to continue to increase, especially as Brazil’s health ministry struggles to accommodate a growing number of patient lawsuits seeking access to medicines.
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Market Entry
For medical products, foreign medical equipment/devices suppliers must establish a local office or assign an agent or distributor to sell their product in Brazil. Due to the vast geographic size of the country, significant diversity amongst regions, regional economic disparities, and varying states of infrastructure, it is generally recommended to have multiple distributors in Brazil. The main cities of Brazil include São Paulo, Rio de Janeiro, Belo Horizonte, Brasília, Porto Alegre, Salvador, Recife, and Curitiba.
Setting up a company in Brazil or acquiring an existing entity can be a relatively complex option for Brazil, although the new program “Balcão Único” created by the Ministry of Economy aims to simplify the process.
Some companies are doing joint ventures with Brazilian entities that provide final assembly and packaging of products. For some industries, this option can reduce import duties and import documentation that is required for finished goods. Additionally, the Brazilian Government provides a preference in the public purchase of medical products for locally made products.
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Current Market Trends
Despite Brazil’s recent economic downturn, private and public hospitals still have great purchasing power, and with continued expansion of Brazil’s private health care sector, the market is expected to grow. New opportunities for US exporters exist in many sub-sectors including:
- Clinical Chemistry, Biomedical and Advanced Medical Devices – high demand for new technologies;
- Laboratory Equipment – investments in R&D, including some tariff and registration exemptions;
- Disposables and Surgical – high usage at 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 number of dentists in the world;
- Drugs, Pharmaceuticals and Nutrition Supplements – high dependency on imported products.
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Market Size
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Healthcare spending (including investment)
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US$ 40 billion (R$ 200 billion) (2021)
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… as percent of GDP
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9.1%
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Hospitals, Procedures, Healthcare Professionals
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Number of hospitals
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6,778
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…Public
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2,033
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…Private
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4,745
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Number of hospital beds
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494,000
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… available beds per capita
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23,78 per 10,000 habitants
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…of which in general hospitals
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116,770
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…of which in specialized clinics and rehabilitation centers
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377,327
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Number of surgical procedures
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6,168 per 100,000 habitants
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…of which [top procedure]
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plastic
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…of which [second highest procedure]
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|
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Physicians
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432,070
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…of which surgeons
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38,022
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…of which internists
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20,566
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…of which pediatricians
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45,367
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Dentists
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270,000
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Demographics
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Population
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214,850,000
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Life expectancy men/women
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71.9 men, 79.8 women
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Infant mortality
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12.4%
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Percent of population older than 65
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10.53%
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…projection, 2030
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13.44%
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Annual deaths
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6.6%
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1. Use any information available from CIA World Factbook or other more recent sources first. Most data from CIA World Factbook is updated as of 2016.
2. The UN database has various healthcare statistics on all countries. To find more go to http://data.un.org/Explorer.aspx?d=WHO. Then click WHO Data (World Health Organization). Then click World Health Statistic and explore the different subcategories.
3. When using the UN database, notice that for each country they have statistics for past 5 or so years. Pull the latest statistic.
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Main Competitors
There are few high-quality Brazilian manufacturers of advanced medical products so Brazil’s reliance on imports should continue for some time. Local buyers view U.S. and other foreign products (primarily Canadian and European) as having comparable quality and reliability. Thus, financing terms often become the differentiating criteria in making a sale.
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Current Demand
The market for home health care products has increased by 5% annually and the market size is estimated at $1 billion USD. Brazilian health insurance companies are responsible for paying 90% of the costs related to home care treatment.
U.S. exporters should consider the opportunities offered by Mercosur, and potentially use Brazil as a “spring board” for export into Argentina, Uruguay and Paraguay. Since compulsory product registration before sale is required for all of Mercosur countries, U.S. exporters should consult a local lawyer/consultant before signing a contract with any agent/distributor.
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Registration Process
For registration purposes, products classified as risk grade I and II requires the cadastro, which is the simplified form for new medical products. Class III and IV products require a more detailed registration process, that includes the certificate of Good Manufacturing Practices. ANVISA accepts the single audit program, which, in conjunction with other international health agencies, recognizes the GMP certificate audited by third party companies. Also, as part of the process to reduce bureaucracy, ANVISE allows the transfer of product registration among companies. Foreign companies must assign a Brazilian representative or establish a local office in order to submit the registration/cadastro petitions to Anvisa. Products considered as essential for the government may have an expedited registration process.
For further information about the registration of medical products at Anvisa, visit the website: http://portal.ANVISA.gov.br.
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Reimbursement
Payment in Brazil is made through pay per service, however there are initiatives to implement the fee per performance format in order to avoid costs in the public and private systems. ANS, the National Agency of Health, establishes a list of procedures and prices that private insurance companies must provide to their associates. For updates on the procedures and values, ANS weblink is: https://www.gov.br/ans/pt-br.
CONITEC is the National Counsel for the Implementation of Technology into the Brazilian Health Public System (SUS), that advises on the acquisition or retirement of technologies: http://conitec.gov.br/.
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Barriers
Medical products in Brazil are regulated by ANVISA, the Brazilian equivalent of the FDA. All products must be registered or notified to obtain a sales license. For products with a higher grade risk or considered strategic for the public system, it may be necessary to have additional local certifications for electric components, economic market data from other countries and inspections in manufacturing plants.
Brazil’s import system is very complex and can add as much as 100% of the value of the product when factoring in freight, tariffs and taxes. Import tariffs for medical products vary from 0 to 18%. For a more detailed explanation about how to do business in Brazil: https://www.trade.gov/brazil-country-commercial-guide.
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Procurement & Tenders
Companies can participate in bidding processes for Federal or State/Municipal tenders for healthcare products and services. It is recommended that companies check opportunities on the portals of each state. For Federal tenders and regulations, the link is: http://portalsaude.saude.gov.br/.
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U.S. Commercial Service Contact Information
Name: Jefferson Oliveira
Position: Commercial Specialist
Email: Jefferson.oliveira@trade.gov
Phone: 55-11-3250-5136
