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
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
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
On June 1, 2014, China's amended "Regulations on the Supervision and Administration of Medical Devices" went into effect. Class I medical devices -- domestic and imported -- no longer need to be registered with the China Food and Drug Administration (CFDA). Instead,... Read More
As noted in last month's eNewsletter, China has been working on significant revisions to its medical device laws. On March 31, 2014, the Chinese government released amendments to the "Regulations on the Supervision and Administration of Medical Devices." Read More
China's medical device market has grown to $13 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers registering their products in China has grown exponentially. View our webcast to learn about the new regulations in China.... Read More
At the end of June, Korea’s Ministry of Food and Drug Safety (MFDS) announced three major changes to the country’s Medical Device Act. The first requires that all Class IV medical devices undergo registration using the Summary Technical Document (STED) format starting... Read More