Archives

美国食品和药物管理局（FDA）有几个试点项目正在进行中，应该使许多医疗器械的注册申请更加简单和快捷。对于上市前通知，510（K）电子申请（eSubmissions）计划将引导企业将申请文件合并，并提交510（k）申请- 可加快审评进程。该试点项目，于2014年7月开始，正在迅速扩大。该计划最终将覆盖更多类型的医疗器械申请，包括上市前批准（PMA）申请。 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... 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... 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,... 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... 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... 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... 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

2014年8月1日，美国食品和药物管理局（FDA）宣布2015年的制药和医疗设备申请费。 这些费率将在2014年10月1日至2015年9月30日有效。对于医疗器械，上市前申请（PMA）将耗资250，895美元；510（K）上市前通知将提高到5018美元。 Read More