PBM 公司正在进行一项新的以佣金为基础的亚洲销售计划
亚洲医疗市场在过去的25年经历了指数级的增长。今天,中国和日本已经是全球排名前5位的大的医疗器械市场。要成功地发展其业务,西方的医疗器械公司应该考虑进入或扩大在亚洲的医疗器械市场的份额。 Read More
亚洲医疗市场在过去的25年经历了指数级的增长。今天,中国和日本已经是全球排名前5位的大的医疗器械市场。要成功地发展其业务,西方的医疗器械公司应该考虑进入或扩大在亚洲的医疗器械市场的份额。 Read More
泰国食品和药物管理局(FDA)最近宣布,对于药品注册申报资料实行电子版通用技术文件(eCTD)试点。该试点项目将于2014年10月开始。从试点中获得反馈后,泰国FDA的电子提交系统将于2015年5月全面实施。 Read More
亚洲人心脏衰竭发生的平均年龄在61岁 Read More
China: Medical Device/In Vitro Diagnostic Clinical Trials Update On July 30, 2014, the China Food and Drug Administration (CFDA) released detailed information on implementing the revised Regulations on the Supervision and Administration of Medical Devices. Order No. 4 covers Administrative Measures for... Read More
Medical devices in India are regulated under the Drugs and Cosmetics Act, which focuses on drugs and not devices. As of now, there are no separate medical device regulations, although a new medical device bill has been pending in India for over... Read More
The Thai Food and Drug Administration (FDA) recently announced an electronic common technical document (eCTD) pilot program for drug application dossiers. The pilot program will start in October 2014. After feedback from the pilot, the Thai FDAs electronic submission system will be... Read More
Asians develop heart failure at an average age of 61, approximately a decade earlier than patients in the U.S. and Europe. Because many Asian patients do not understand the disease or the early stage symptoms, the five-year survival rate is very low.... Read More
The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application -- resulting... Read More
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