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
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 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
PBM在七月简讯报道，中国修订了医疗器械的监督管理条例并于6月1日开始生效。2014年8月1日，中国食品药品监督管理局（CFDA）公布法规修订后的实施细则。这些实施细则将于2014年10月1日开始生效。 Read More
As PBM noted in a July news brief, Chinas revised Regulations on the Supervision and Administration of Medical Devices went into force on June 1, 2014. On August 1, the China Food and Drug Administration (CFDA) released additional detailed information on implementing... 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
在过去的几个月，马来西亚医疗器械管理局（MDA）发布了几条消息。2013年年中，首次网上推出，医疗器械集中式应用系统（MEDCAST）。于2014年5 月支持在体外诊断（IVD）仪器的申请。 MDA公布了体外诊断试剂的12步注册程序。 另外2014年5月，MDA的颁布5项新政策，进一步落实医疗器械法： Read More
已获得中国食品药品监督管理局（CFDA）批准的药物，通常需要一年半的时间医生才可以给病人使用。为尽快让病人使用上已经批准的药物，一些制药公司开始在药物获得批准以前，就开始着手价格审批，招投标和医院上市的工作。中国的药品定价，是指医院进行的药品定价和药品采购。确定进口药品的价格与设定国产药物的价格，有所不同。 Read More