Industry news and insights

Get the latest information on the U.S. and LatAm healthcare market with updated news, reports, articles and data

Class I and Class II medical devices: defining, classifying and marketing them

The Food and Drug Administration (FDA) is the regulatory body governing medical devices with a variety of enforcement tools at its disposal, such as seizure, injunction, prosecution and civil penalties.

This brief serves as a quick guide for the FIME audience on how and where to submit an application, as well as information about device classification, required documentation, approval processes, and application fees, among others.

Read the report to learn more.

U.S. medical devices: imports and exports, and the role of the FDA

With the United States leading the world as the largest medical device market, there is a growing interest from manufacturers and distributors to partner and expand the distribution of medical devices and equipment between Latin America and the United States.

However, many requirements need to be met to make these endeavors a success.

Read the report to learn more.

Medical device tax still weighs on the minds of medtech execs

The medical device excise tax is scheduled to restart in January after being suspended for the last four years (for two consecutive two-year periods). Will the industry's renewed lobbying efforts get the tax repealed once and for all?

Refurbished medical devices market in North and Latin Americas

The refurbished medical equipment market contributes to grand societal challenges by reducing waste and conserving resources; increasing access to healthcare in markets with increasing healthcare cost pressure; and offering economic benefits from extending the life cycle value of manufactured equipment and creating new jobs, growth and investment.

Read the complete report to find out more.

Tariffs: Is Mexico the next China?

The medical device industry is keeping a close eye on the relationship between the United States and its immediate neighbor to the south. The countries reached a deal to indefinitely suspend proposed tariffs after the U.S. announced earlier this year that it would impose a 5% tariff, eventually set to rise to 25%, on all imports from Mexico, including medical devices.

The United States relies on Mexico for 17% of its medical device imports. It could potentially be devastating to the medical device industry and, ultimately, to patients. Read more about tariffs on medical devices in this report.  

Healthcare Innovation & the Digital Health Landscape in Latin and North Americas

The global digital health market generated US$ 73.1 billion revenue in 2017 and is predicted to observe a tremendous growth, with a CAGR of 21.1%.

Check out the key figures, trends for 2019 and see how the future of innovation on healthcare can affect your business goals.

Read the report to find out more.

Healthcare market insights in Latin and North Americas

US spends 17.8% of GDP - this is the highest percentage in the world. The global average is just 6.8%.

Check the overview of market forces, key trends, healthcare spending and other factors affecting the US and Latin American healthcare marketplace.

Read the report to find out more.