After four years of negotiations, European lawmakers have agreed on a new EU Medical Devices Regulation (MDR). The MDR is the alike the US FDA’s CDRH regulations and fundamentally postulates the appropriate rules when introducing m…
Brazil has the largest economy and medical device market in Latin America, but per capita medical expenditure is still very low. The highest expenditure is in the large cities, such as São Paulo or Rio de Janeiro, but producers are moving into regional markets outside the major state capitals. The medical device market in 2013 is valued at US$5,918.9mn, equal to US$29.6 per capita.
The public health system (SUS), created in 1988, provides healthcare services to around 75% of the population and the private sector 25%. However, the majority of inpatient services within the SUS are operated by private providers, with more than two-thirds of hospital facilities operated by the private sector. Further private investment in the health sector is being encouraged through a public-private partnership scheme launched in 2008, which is supported by the International Finance Corporation, the Brazilian Development Bank and the Inter-American Development Bank.
Brazil has the second largest private health insurance sector in the Americas, after the USA, covering around 25% of the population, 48mn people, in 2012. The expansion of the private health insurance sector in recent years has resulted in demand for better medical care and, in turn, further expenditure in medical equipment. The economic downturn has not affected hospital capital investments so severely. The public sector continues to be modernised and to upgrade obsolete equipment, therefore there are sizeable market opportunities if prices are competitive.
The government is extending healthcare service access through its Mais Saúde programme launched at the end of 2007, phase 2 of which is set to run until 2014. This programme has focused attention on developing the primary care network.
The government continues to invest in the expansion of the SUS. In 2013, BRL2.3bn (US$1.1bn) will be invested to support the development of primary health and emergency care services. A total of BRL$1.39bn (US$662mn) has also been invested in university hospitals since 2010 under the National University Hospital Restructuring programme (REHUF), which aims to improve access and quality of tertiary services provided to patients as well as the working and training conditions of medical students.
Medical device mports hold a relatively small share of the market, totalling US$2.8bn in 2012. They increased by 8.0% in 2012, but the CAGR 2007-2012 was much higher at 14.8%. Imports tend to be hightech medical equipment not produced locally. In 2012, over 75% of imports were supplied by Europe and the USA.
Brazilian medical device exports totalled US$524.6mn in 2012, a fall of 5.4% over 2011. The country has a well-established medical industry, comprising local and multinational companies. Domestic production, however, is geared towards the local market. Exports are small in comparison with total production and the country consistently runs a negative balance of trade in medical equipment and supplies.