Unlike some other emerging markets, China has a medical device regulatory system in place that is both substantial and challenging.

Adhesives offer a number of advantages over other fastening systems. Today, a number of adhesive are available and there is no such thing as “one adhesive fits all.”

Is the 510(k) process ideal? Far from it. But it generally does a very good job at what it’s supposed to do: make a risk-based assessment of new or modified products before permitting them on the market, while keeping the evidentiary burden on companies at realistic levels, and rely on postmarket surveillance to capture problems.

Thinking of marketing your product in China, India or Brazil? What do you need to know?

It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedicalDeviceSummit presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.

The 2011 Medical Device Industry Outlook survey, conducted by Emergo Group and Medical Device Summit, has revealed cautious optimism. In terms of indicators such as expansion into new markets, expected sales trajectories and salary outlooks, the medical device industry expects to see a healthy rate of growth this year. More than three quarters of respondents expect overall sales to increase, with many seeing significant increases in international orders, and planning to expand into emerging international markets. More than half of respondents plan on hiring more in 2011.