Ready to sell your medical device in the United States? The first step is to classify your device according to the US FDA classification system. And as many medical device manufacturers know – this is not an easy task.

Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK. Registering a device there can be a complex process, due mainly to the constantly evolving regulations.

Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key markets, you are well on your way to TGA compliance.

Interested in selling your medical device in Saudi Arabia? If so, there are a lot of things to know about Saudi Arabia's regulatory process before you get started. The Saudi Food and Drug Authority (SFDA) relies on reference market approval, but it is not a "rubber stamp" registration.

Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK. Interested in getting your share of the Brazilian market? This video provides a brief overview of what it takes to get your device registered there.

Thinking of selling your medical device in Mexico? Mexico can be a lucrative market, and it imports the majority of its medical devices from the US and Europe. However, registration is not a simple process, and products can be grouped into the same product family depending on a variety of factors.

Japan is the largest market for medical devices in Asia. Though Japan has less than one-tenth (1/10) the population of China, the Japanese spend more on healthcare. An aging population and high per-capita spending make it an attractive and potentially lucrative market for medical device manufacturers. Interested in entering this market?