The China Food and Drug Administration (CFDA) issued more comprehensive guidelines for manufacturing three types of medical devices: sterile and implantable devices, and in-vitro diagnosis reagents. The guidelines for medical device manufacturing in China come into effect on October 1, 2015. The... Read More
This article was also published on MedTech Intelligence As one of the fastest developing regions in the world, Asia’s strong economic growth, coupled with its burgeoning middle class, has led to greater demand for better healthcare service. Over the next five years,... Read More
Last year, China released the “Procedure for Examination and Approval of Innovative Medical Devices (Trial)”, which went into effect on March 1, 2014. The Chinese Food and Drug Administration (CFDA) defined certain conditions that the applicant must fulfill in order to qualify... Read More
In recent years, China’s healthcare sector has been received increasing scrutiny from the Chinese government. Extensive corruption investigations have made their way into the medical industry. The Chinese government has begun investigations on a number of top Chinese healthcare officials. The Central... Read More
In early July, the Chinese Food and Drug Administration (CFDA) announced that they will begin to conduct regular surprise inspections of pharmaceutical and medical device manufacturers starting on September 1, 2015. In addition to the regular inspections, a manufacturer may also be... Read More
2015年5月下旬，中国食品药品监督管理局（CFDA）宣布提高药品和医疗器械的注册申请费用 – 立即生效。政府收取的注册申请费对进口医药产品将增加至156,500美元，而进口仿制药的申请将耗资140,250美元。 对于进口II类医疗器械，政府收取的注册申请费将为34,000美元,进口第三类医疗器械将收费49,800美元。这是一个巨大的成本，因为之前政府不对医疗器械的注册申请收取任何费用。高风险医疗器械的临床试验申请将花费近7,000美元。医疗器械需要每隔五年重新注册，II类和III类医疗器械的延续注册费用都为6,580美元。 如果CFDA从增加的注册收费所得用以加强其监管程序，那么产品审批时限可能会降低。目前，中国的医疗器械产品注册往往需要一到三年。而另一方面，药品可能需要6-8年才能拿到注册批准进入中国市场。 Read More
中国食品和药物管理局（CFDA）最近发布了第二类、第三类医疗器械的临床评价制导原则。该指导原则还概述了CFDA所需的文件。 如果医疗器械被证明等同于CFDA免于临床研究的目录上的其他产品，则该产品可以获得临床试验豁免。如果一个器械产品被确定为基本上等同于已经在市场上上市的其他产品，在中国也不需要在进行临床试验。这意味着，两个医疗器械产品的材料、安全性、生产过程、预期用途、产品结构和操作上的任何差异必须不会对该器械产品的疗效和安全性产生任何明显的影响。此外，从目前市售器械获得的临床研究和使用数据可以用于提交“新”器械产品的注册申请。 对于那些需要进行临床试验的医疗器械，CFDA在某些情况下仍可能接受来自国外的临床研究数据。在这种情况下，试验设计应符合中国的标准。某些高风险的设备 – 诸如可植入起搏器、血管内支架和人工器官 – 将需要在注册申请过程中在中国进行临床试验。对于一些低风险的设备，从文献评估和上市后使用中获得的数据已经足够用于注册申请。 Read More
In late May 2015, the China Food and Drug Administration (CFDA) announced an increase in drug and medical device registration fees – effective immediately. The government registration fee for imported pharmaceutical products will increase to $156,500, while imported generic drugs will cost... Read More
China’s Food and Drug Administration (CFDA) recently released guidelines for the clinical evaluation of Class II and Class III medical devices. The guidelines also outline the documentation required by the CFDA. A clinical trial waiver may be granted if the device is... Read More
今年3月30日，中国国务院发布了一系列目标，作为最新的中国医疗卫生服务体系5年规划的一部分。这些改革预计将增加对医疗器械和医药产品在中国市场的需求。该规划要求： · 通过提高城镇和农村居民的医疗补贴，提高基本医疗保险的覆盖 · 降低药品价格 · 提高医疗服务费用 · 增加对公共卫生服务的投入 · 增加诊所和医院的数量，包括私立医院（到2020年，预计30％的医院将是私人机构，而现在为10％） · 增加基层医生和护士的数量 · 通过技术应用实现更好的医疗服务，包括可穿戴设备 中国政府还致力于私有化和降低对医疗保健部门的外国投资的限制。到2020年，中国医疗市场预计将价值超过9000亿美元。 Read More