Brazil - HealthcareBrazil - Healthcare
- Pharmaceuticals and Nutritional Supplements
- Medical Devices/Health IT
Brazil is the largest healthcare market in Latin America and spends 9.1% of its GDP in healthcare. Of the approximately 6,500 hospitals, 70% are private. There are approximately 495,000 hospital beds, 96,000 healthcare supplementary services, 432,000 physicians, 144,000 dentists, and 70,000 drugstores.
Experts speculate that the Brazilian healthcare industry will recover quickly from Brazil’s recent economic recession. In 2018, investment in R&D for healthcare products could reach US$ 165.8b, a growth of 4.7% from 2017. (Source: ABIIS).
Pharmaceuticals and Nutritional Supplements
Brazil ranks among the top seven markets in size for drugs and pharmaceuticals, with sales of US$ 29.9b in 2017 (including taxes – Source: Sindusfarma). In 2018, a new decree from ANVISA, the Brazilian Agency of Sanitary Surveillance (Brazil’s FDA equivalent), will adjust limits for daily intake, labeling, claims, and new products in the nutritional supplements and vitamins categories.
In 2017, Brazil imported US$ 6.5b in medicines and raw materials and is expected to reach US$ 6.6b in imports by the end of 2018. For high value-added medicines, the United States and Europe are the main exporters to Brazil, while China, India, and Ireland are the main suppliers of raw ingredients.
Medical Devices/Health IT
For medical devices, the market size is approximately US$ 10.8b (Source: Abimed). Brazil is part of the Medical Devices Single Audit Program (MDSAP), in conjunction with the United States, Japan, Canada, and Australia for the acceptance of a mutually-recognized international audit program performed by a third-party company. This can expedite processes of approval for new products in the country, though ANVISA maintains their fee, in addition to the MDSAP fees.
The Ministry of Health announced possible investments of more than US$ 450m by 2019 to digitalize the public basic care units of the country’s Unified Health System (SUS). Private hospitals are also investing in technology and several new hospitals are formalizing their progress by obtaining international certificates for data management and reduction of paper use.
Brazil imports an estimated 80% of its medical equipment, with only 29% originating from the United States. Brazil is the 14th largest market for U.S. medical devices and second in Latin America, after Mexico. In 2017, U.S. medical device exports to Brazil reached US$ 1.08b, an increase of 2.5% from the previous year. (Source: Census Bureau, U.S. Department of Commerce).
2017 Total Imports of Medical Equipment into Brazil
|Group of Products||Imports|
|Orthesis, prosthesis and Special Materials (OPSM)||312||-4 %|
|Equipment and Support Materials for OPSM||1,061||3 %|
|Reagents for In Vitro Diagnostics (IVD)||3,951||22 %|
|Materials and Equipment for IVD (except IT)||2,040||-16 %|
|Other Medical Equipment including Laser||817||-2.4 %|
|Imaging Diagnostic Equipment and supplies||463||4.9 %|
|Laboratory Equipment||906||-3.9 %|
|Dental Material and Equipment||113||30 %|
|Materials and Supplies||951||13.1 %|
|Other IT for IVD||2,143||13 %|
Principal Business Associations
- ABENUTRI - The Brazilian Association of Nutritional Products (http://www.abenutri.org)
- ABIIS - Brazilian Alliance for Innovation Healthcare Industry (https://abiis.org.br/abiis-health-4-0/)
- ABIMED -Brazilian Association of High Technology Industries of Medical Devices (https://www.abimed.org.br)
- ANVISA - Brazilian Health Regulatory Agency (http://portal.anvisa.gov.br/english)
- BRASNUTRI -Brazilian Association of Manufacturers of Nutritional Supplements and Special Food (http://www.brasnutri.org.br)
- Interfarma - Brazilian Association of Pharmaceutical Research Industry (https://www.interfarma.org.br)
Limitations on Selling U.S. Products and Services
U.S. healthcare products must follow regulations established by ANVISA. While certain low risk products may be exempt of registration, it is mandatory to have an importer or distributor for product liability. Also, it is recommended that foreign companies have local technical staff and replacement parts for customer support.
Labeling /Marketing Requirements
Labels must be in Portuguese, however it is acceptable to add a sticker to the package/bottle with the translated information. For nutritional supplements/herbs/vitamins, companies must follow specific guidelines to make certain claims. Products marketed with therapeutic effects are considered drugs and must provide efficacy and safety tests.
Import Requirements & Documentation
Medical devices are classified in four levels of risk: Class I for low risk, Class II for medium risk, Class III and IV for high risk (temporary and long term invasive products). Higher risk products demand inspections in the manufacturing plants for quality control certifications while lower risk products may be exempt of the registration process. Foreign companies must assign a local representative to submit the documentation for ANVISA, which regulates the sanitary authorizations for sales of medical products. Other agencies such as INMETRO (for electric/battery operated products) and Anatel (wifi devices) may also be involved in certification of products. The U.S. Commercial Service in Brazil can assist with making those connections. Please work with your importer to ensure all documents are correct to avoid delays and fines imposed by Brazilian Customs over improper paperwork.
Selling to the Government
The GoB is the main buyer of healthcare products to supply the public healthcare system. Foreign companies can participate in bids as long they have local representatives, with some exceptions. It is also possible to participate in a Productive Development Partnership (PDP). PDPs are designed to allow international companies to partner with local laboratories to supply the public system for a period of up to five years, with a reserved market share, and with the goal of a technology transfer at the end of the contract. Companies should be well-prepared and fully investigate all terms before committing to a PDP.
Distribution & Sales Channels
In general, U.S. companies should pursue local business partners to cover the most important commercial regions. Large distributors in both medical equipment and drugstores are likely to prefer products that are already available in the market instead of importing directly from foreign suppliers. Regulations prohibit sales of medicines and medical devices outside of specialized medical stores or pharmacies.
E-commerce is a growing channel for end-users to acquire imported products, if they are for personal use. To reduce returns, sellers should inform customers that Brazilian Customs charges fees to clear imported goods. With regards to products for sales, professional treatment or diagnostic use, importers should follow the regular commercial procedures for importation.
In Brazil, the healthcare market is price-driven, mostly towards products that are manufactured in country. Quality is also important and companies must meet all sanitary registration requirements to sell to the Government. Foreign companies should consider cost-saving concepts and make clear the benefits of new technologies in marketing and promotional materials.
Healthcare, Life Sciences, and Biotech Sectors
Brazil Healthcare Trade Development and Promotion