Regulations Explore The Medical Device Industry Marketing Process And Breakthrough

Medical Devices Industry is a new bloom, and high technique complex industry. It also diversifies in species, permeable sale and highly regulated by specified regulation in every countries. In recent years, the growth of medical devices sales worldwide is in 5% increase. It is also increased 3-10% for export in Taiwan.To sale in this industry, to get a "ticket" is the first priority. The "ticket" means to get "market approval" then sale in the market. Once the products put into market, the post market surveillance is started according to the regulation requirement. There must have an accurate traceability system. When the market has any feedback, it must ready for reporting. If necessary, recall or announce advisory notice.The sale channel is closed. Not only a closed sale channel, but also a conservative market module. However, once get into this market, it is not easy to be affect by the environment.There are some advises provided in this thesis for Taiwanese medical device industry about how to face the regulation during sale. Meanwhile, giving some suggestions for medical device craft-bother, those who willing to get in to this industry and regulatory authority. In this study, there are some advices for the future sale direction included develop high quality regulated products, focus on the home-care or center-care module, take look at on the elder society medical caring, develop multi-in-one, micronized and new-tech machines.In the summaries, it reminds the persons who in this industry to realize the "market approval" is the ticket for into this market not an amulet. It should be to bring up the ability of combination with other industries' techniques, to enforcement the quality of personals, to establish the concept of management which based on the risk control.