Healthcare Policy Issues
Current Market Trends
Procurement & Tenders
GDP: U$ 2.081 trillion
Brazil’s medical devices are regulated by ANVISA, with both ANVISA and INMETRO, the national Brazilian standards agency, issuing standards and guidance to which medical devices companies must comply. In 2016, INMETRO introduced new requirements for market authorization, including localized product safety conformity assessment testing for electromedical devices, which results in additional time and cost for some U.S. companies exporting medical devices to Brazil. The pharmaceutical sector faces a complex and difficult patent system, excessive bureaucracy and strict price controls. Because patents need to be reviewed by both ANVISA and the National Institute of Industrial Property (INPI), it takes an average of 11 years to grant or reject a patent application in Brazil. Brazil is taking steps to remove onerous regulations for reviewing and approving clinical trials, which should lower clinical trial approval times from the current 15 months to 2-3 months.
Brazil is the largest medical equipment market in South America and it is expected to recover from recent retraction soon. Medical equipment revenues in 2017 reached an estimated US$ 10.8 billion. According to the World Bank, in 2017 private and public healthcare expenses in Brazil corresponded to 9.1% of GDP.
The United States accounts for approximately 28% of the import market in Brazil. In 2017, imports of medical products and devices were US$ 8.6 billion, with a growth of 5.4% from the previous year.
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%. For industry highlights, visit the weblink: http://export.gov/brazil/industryhighlights/index.asp
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 regulations to which medical devices companies must comply as well as standards. As of 2017, the Brazilian government has been studying 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 also 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 is 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.
The pharmaceutical sector faces a complex and difficult patent system, excess bureaucracy, and strict price controls. Because patents for pharmaceuticals need to be reviewed by both ANVISA and the National Institute of Industrial Property (INPI), it takes an average of 11 years to grant or reject a patent application in Brazil. 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. Pricing pressure is expected to continue to increase, especially as Brazil’s health ministry struggles to accommodate growing patient lawsuits seeking access to medicines.
For medical products, foreign medical equipment/devices suppliers must establish a local office or assign an agent or distributor to sell in Brazil. Due mainly to regional economic disparities and varying states of infrastructure, it is often difficult to find one distributor that has complete national coverage. The main cities are São Paulo, Rio de Janeiro, Belo Horizonte, Brasília, Porto Alegre, Salvador, Recife and Curitiba.
Either setting up a company in Brazil or acquiring an existing entity can be a relatively complex option, although the Ministry of Development has signaled intention for simplified process.
Companies are also joint venturing with Brazilian industries for final assembling and packaging of products. For some industries, this option can reduces import duties and documentations that are required for finished goods. In addition, the Brazilian Government is offering margins of preference in the public purchase of medical products for locally made products.
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 healthcare sector, the market should grow. New opportunities for U.S. exporters abound, particularly for:
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 (mainly Canadian and European) as having comparable quality and reliability. Thus, financing terms often become the differentiating criteria in making a sale.
The market for home healthcare products has been increasing in 5% every year and is estimated in US$ 10 billion. 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 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.
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, and 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, ANVISA allows the transfer of registration of products 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 registration of medical products at ANVISA, visit the website: http://portal.ANVISA.gov.br
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, visit ANS.
CONITEC is the National Counsil for Implementation of Technology into the Brazilian Health Public System (SUS, They advise on the incorporation or disinvestment of technologies. http://conitec.gov.br/
Medical products in Brazil are regulated by ANVISA, the Brazilian counterpart of FDA. All products must be registered or notified in order to obtain sales licenses. For products with a higher risk grade 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 up to 100% fees over products in general However import duties for medical products vary from 0 to 18%.
For a more detailed explanation about how to do business in Brazil: http://export.gov/brazil/doingbusinessinbrazil/index.asp
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/index.php?option=com_content&view=article&id=6749
1. Who should hold the registration of my products in Brazil?
A Brazilian local entity must be responsible for the registration of medical products. U.S. companies should be aware of terms and conditions in the agreements with a Brazilian partner, mostly related to payment conditions, exclusivity and expiration of contract. Some importers may request to have the exclusive license to distribute the products in the country while registration holders may offer more flexibility to work with multiple distributors. Registration holder companies charge annual fees for holding the registrations of manufacturers. U.S. companies can also partner with local Brazilian companies for one specific line of product, for the period that agreement will be valid. The U.S. Commercial Service recommends that foreign companies contact lawyer services to verify if the contracts will cover their interests in Brazil.
2. How long does it take to register a product in Brazil?
Anvisa has changed regulations in order to expedite the process for lower risk products. Regulations inform that the analysis of registration submissions should be complete in 90 days, however it is frequent that products may obtain approvals after more than one year of the application. Electric or battery operated devices, Wi-Fi components, in vitro diagnostics, implants and other high risk products may require additional certifications in order to complete all requirements for registration. Incomplete or erroneous dossies can also cause delays in registration processes.
3. Can I sell refurbished or used products in Brazil?
Brazilian regulations are strict in relation to pre-owned medical products. Products must be refurbished by OEM, using original spare parts and having the same performance and guarantee as a new equipment. Resellers of used equipment have very limited market access in Brazil.
Healthcare spending (including investment)
U$ 40 billion
... as percent of GDP
Hospitals, Procedures, Healthcare Professionals UN
Number of hospitals
Number of hospital beds
... available beds per capita
32,53 per 10,000 habitants
...of which in general hospitals
...of which in specialized clinics and rehabilitation centers
Number of surgical procedures
6,168 per 100,000 habitants
...of which [top procedure]
...of which surgeons
...of which internists
...of which pediatricians
Life expectancy men/women
70.5 men, 77.7 women
Percent of population older than 65
U.S Commercial Service Contact Information
Name: Jefferson Oliveira
Position: Commercial Specialist
Notice to Visitors!
The link you have chosen will take you to a non-U.S. Government website.
If the page does not appear in 5 seconds, please click this: outside web site
Export.gov is managed by the International Trade Administration and
external links are covered by its website disclaimer statement.
BuyUSA.gov is managed by the International Trade Administration and
external links are covered by its website disclaimer statement.