The ten nations that make up the Association of Southeast Asian Nations (ASEAN) -- Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- together have a population of over 610 million, almost twice the population of the U.S.... Read More
Healthcare corruption in China was a big news item in 2013, with investigations conducted into milk powder firms as well as both domestic and international drug companies, such as GlaxoSmithKline (GSK). Chinese authorities have vowed to increase food product safety checks and... Read More
2013年12月17日，中国国家食品药品监督管理总局 （CFDA）发布简化版医疗器械重新注册流程，该流程于2014年1月1日开始生效。更新后的流程将减小生产商方面的文书负担，加快认证更新的通过时间，从而让核准机关可更专注于产品上市后的监管和新产品认证。这一举措是食药监总局加强和简化医疗器械管理的系列步骤中的最新举动。 Read More
在日本没有分部的外国生产商必须委任一家上市许可持有商（以下简称MAH）或一家上市许可持有代理商（以下简称dMAH）来管理医疗器械注册事宜并与日本药品和医疗器械综合管理机构（PMDA）进行沟通。 Read More
On December 17, 2013, the China Food and Drug Administration (CFDA) announced a streamlined device registration renewal process that took effect on January 1. The updated process will reduce the burden of paperwork on manufacturers, result in faster renewal certification approvals and... Read More
Foreign manufacturers with no local presence in Japan must appoint a Marketing Authorization Holder (MAH) or a designated MAH (dMAH) to manage their device registrations and liaise with the Pharmaceuticals and Medical Devices Agency (PMDA). Both MAH and dMAH must be based... Read More
Japan is the second largest medical device market in the world. Getting through the registration process and selling your product on the market is not an easy task. This webcast will focus on key steps including PMDA consultation sessions, how to maximize... Read More
重组后的中国国家食品药品监督管理总局（CFDA）将加大对于医疗器械上市后的监管力度。其中的改变包括对不良事件报告的处理以及医疗器械重新注册。这两项程序将在2014和2015年经历重大改变。 Read More
印度尼西亚引入医疗器械电子注册系统，此举是为其于2015年1月融入东南亚国家联盟（ASEAN）法规体系做准备。同时对于医疗器械及相关附件的海关申报也出台了明确规定。 Read More
As China's Food and Drug Administration (CFDA) undergoes reorganization, it is placing more emphasis on post-market compliance for medical devices. This includes changes to processes such as Adverse Events (AE) reporting and the re-registration of medical devices. Both of these processes will... Read More