Keys to FDA approval and medical device business in the US ~ How to succeed in the world largest medtech market ~

The presentation will cover the structure of the U.S. FDA, as well as regulatory issues related to medical device applications, registration, quality control, FDA inspections, etc. It will also provide a comprehensive explanation of the U.S. medical device business including insurance system, business practices, negotiations, and other important points to keep in mind to build a successful business. The lecture will be informative for both new entrants and for those who already sell products in the United States. The main takeaways include 1) understanding FDA regulations for medical devices, 2) things you need to know before submitting an FDA application, 3) recognizing measures to be taken in response to FDA inspections, 4) amending the device's current good manufacturing practice requirements of the Quality System Regulation (QSR), and 5) knowledge on how to succeed in the U.S. market. Takahiro (Harry) Haruyama from California, USA will be presenting this session, and Miyuki Nagao, an expert of FDA inspection will be at the booth for your questions.