Healthcare Policy Issues
Current Market Trends
GDP*: U$ 1.796 trillion (PPP)
Brazil is the largest medical equipment market in South America and it is expected to recover from recent contraction soon. Medical equipment revenues in 2016 reached an estimated US$ 10.4 billion. According to the World Bank, private and public healthcare expenses in Brazil corresponded to 8.5% of the GDP in 2016.
The United States accounts for approximately 30% of the import market. In 2015, imports of medical products and devices were US$ 4.6 billion, with a reduction of 16.0% from the previous year. As an exception, dental products presented increase of 10.6% in imports and imaging diagnostics 32.4%.
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 consumable 8%; Dental Equipment 3%; Furniture 2%; Other 19%.
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, excess 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 current 15 months to 2-3 months.
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. However, 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 for Brazil, although the Ministry of Development has signaled an intention to simplify the 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 to that, the Brazilian Government is offering margins of preference in the public purchase of medical products for local made products.
Current Market Trends
Despite Brazil’s recently economic downturn, private and public hospitals still have great purchasing power, and with continued expansion of Brazil’s private health care sector, the market should grow. New opportunities for US exporters abound, particularly for:
o Clinical Chemistry, Biomedical and advanced medical devices – high demand for new technologies;
o Laboratory equipment – investments in R&D, including some duties and registration exemptions;
o Disposables and surgical – high consume from private and public hospitals;
o Diagnostic devices and monitoring equipment – high demand for innovative products
o Orthopedics and Implants – high demand of imported products, despite higher sanitary requirements;
o Health IT – demand in hospitals, including education, telemedicine, big data and integration systems;
o Dental – Brazil has one of the highest number of dentists in the world;
o Drugs, Pharmaceuticals and Nutrition Supplements – high dependency on imported products.
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 US 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 health care products has been increasing 5% every year, and is estimated to have reached US$ 1,0 billion. Brazilian health insurance companies are responsible for paying 90% of the costs related to home care treatment.
US 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, US 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, 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, 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 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 for medical services 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: http://www.ans.gov.br/component/content/article?id=750:central-de-atendimentooqueoseu-plano-deve...
CONITEC is the National Counsel for Implementation of Technology into the Brazilian Health Public System (SUS), that advises for 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 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.
The Brazilian 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
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/index.php?option=com_content&view=article&id=6749
§ Date: November 6-9, 2017
§ Date: January 31- February 3, 2018
§ Date: May 22-25, 2018
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
23,78 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
71.9 men, 79.8 women
Percent of population older than 65
U.S. Commercial Service Contact Information
Name: Jefferson Oliveira
Position: Commercial Specialist
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