The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application -- resulting... Read More
在印度，医疗器械由药品和化妆品法进行监管，而此法规更倾向于药品的管理，而非医疗器械。至今，没有针对医疗器械的单独的法规，虽然新的医疗器械法案在印度已经讨论了超过7年而至今仍然未能出台。 Read More
For more information about the registration process for medical devices in China, please see Medical Device Registration in China. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical... Read More
For more information about device classification and the regulation of medical devices in China, please see China Medical Device Regulations. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific... Read More
There is a wealth of opportunities for healthcare companies looking to expand to the Asian markets. This presentation provides an overview of important business and regulatory issues to consider for medical device companies interested in Asia. To view these presentation slides, please... Read More
For more information about Chinese in-country representatives, please see Local Agent Representation for Medical Products in China. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical... Read More
This Japan drug regulatory PowerPoint presentation covers many basic issues for international drug companies looking to gain more knowledge about the Japanese drug market. It includes information on registering ethical, biological, orphan, and generic drugs in Japan. The presentation also provides information... Read More
For more information about the regulation of medical devices in China, please see Medical Device Registration in China. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge... Read More
For more information about Chinese regulatory agencies and China device registration, please see Medical Device Registration in China. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge... Read More
In late June 2014, the Japanese Cabinet approved Prime Minister Shinzo Abes new economic growth strategy. One of the proposed reforms is to deregulate some of Japans highly protected industries -- including healthcare. A key pillar of Abes economic strategy is expanding... Read More