The World Bank ranks Brazil as the sixth largest country in the world in terms of gross domestic product (GDP) at $2.47 trillion in 2011 GDP, and expects the country to continue to climb the list. Brazil’s increasing growth suggests that it is an attractive gateway to doing business in South America.
Brazil’s implants export market grew 122% between 2006 and 2011, with its implants import market growing 136% during that same time period, according to data from Brazilian Health Devices, a partnership between the Brazilian Medical Devices Manufacturers Association (ABIMO) and the Brazilian Trade and Investment Promotion Agency (Apex-Brazil). The U.S. held position of dominant buyer (24.4%) and seller (32.2%) in 2011 regarding equipment and consumables used in Brazil’s dental, medical, hospital and laboratory industries.
In an effort to further ease business between the two countries, FDA and its counterparts in Brazil, Australia and Canada recently signed a statement of cooperation to develop the Medical Device Single Audit Program (MDSAP) which seeks to provide more effective, efficient and less burdensome regulatory oversight of OEMs’ quality management systems.
Below, professionals and experts provide advice on navigating the landscape of Brazil’s orthopaedic device industry. Also, read our article on how to pass Brazil's inspections to take product to market.
Q&A with Orthopaedic Professionals in Brazil
Brazil is still considered to be an emerging market, which means that the medical device industry is still gaining its footing in areas of organization and regulations. BONEZONE asked the following professionals for their take on the region:
Fabio Ribas, Marketing Manager, Orthofix
Marcos Masayuki Ishi, spine surgeon, Grupo Coluna
Danny Arendt, Manager, Import Department, DMC Group, Razek Equipamentos
In your experience, what unique challenges are faced by companies that do business in the Brazil orthopaedic market? What are the unique advantages?
Fabio Ribas: In my opinion, the main challenges are the domestic implants and the lack of more robust laws on this matter. However, the Brazilian companies do not have a well-established structure to ensure the patents on their behalf. Many companies do not pursue patents in Brazil, and when domestic producers start making copies, it is hard to recover the losses.
The unique advantage to working here is that the surgeons like using new technologies. That, and the insurance companies are still paying good prices.
Marcos Masayuki Ishi: The challenges for new health companies in Brazil, in my opinion, are the high taxes on imported implants that become very expensive to use in our poor health system. Also, lack of orthopaedic surgeons trained in new techniques, and conflicting relations between private and public health system.
Advantages are a growing middle class with access to private health care, and American health insurance coming to Brazil.
Danny Arendt: First, companies’ equipment and consumables will be registered with the Ministry of Health, ANVISA, which depending on the classification can take nine months or more than one year to complete. For all documents and rules, it’s necessary to have a person resident in Brazil with the knowledge to do it.
Advantages: we are a continental country with a huge market, and a gateway to the other South American countries because of our importance in the continent’s political and economic scene.