Japan has become the second largest market for in vitro diagnostics (IVD) in the world. In Japan, the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceutical Medical Devices Agency (PMDA) are the two main regulatory authorities that manage pharmaceuticals, medical... Read More
Singapore’s Health Sciences Authority (HSA) is finalizing guidance on medical devices classification for registration purposes. In July, the HSA issued two documents: GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria; and GN-12-2: Guidance on Grouping of Medical... Read More
中国颁布新的医疗器械注册申请收费草案 Read More
This presentation provides an overview of the Asian medical device markets and covers important regulatory issues for specific Asian countries, including China, Japan, India, Thailand, and Vietnam. To view these presentation slides, please click on Asia Medical Device Markets Overview Presentation ... Read More
China's medical device and IVD market has grown to over $20 billion, the third largest in the world. The number of foreign medical device manufacturers registering their products in China has grown exponentially. To be successful in this fast growing market, view... Read More
Details on China's New Regulation for IVDs Read More
For more information about the regulatory system for drugs in China, please see Pharmaceutical and API Product 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 Singapore’s regulatory framework, please see Singapore 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 Bridge Medical (www.pacificbridgemedical.com) and, if possible, a... Read More
For more information about the regulation of medical devices in India, please see India 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 Bridge Medical... Read More
2014年7月30日，国家食品药品监督管理总局（CFDA）颁布了新修订的医疗器械监督管理条例的实施细则。其中包括局令第4号医疗器械注册管理办法和局令第5号诊断试剂注册管理办法。这些实施细则也涵盖了有关临床试验的最新要求，这些新规定将于2014年10月1日起执行。 Read More