亚洲医疗器械市场的增长
亚洲医疗器械市场的增长 Read More
亚洲医疗器械市场的增长 Read More
Singapore’s Health Sciences Authority (HSA) is planning to transfer regulatory control of drug products, currently regulated under the Medicines Act and the Poisons Act, to the Health Products Act. The HSA believes that this will help update, clarify and streamline Singapore’s existing... Read More
新加坡卫生科学局(HSA)计划对药品注册的监管进行转移,从目前的在药品法和毒药法令的监管控制下,转移到保健品法案下进行管理。HSA认为,这将有助于使目前新加坡的药品注册监管更新,更透明和简化。 根据所提议的改变,药物将被称为“治疗产品”,定义为“一种保健产品,其预期用途是以治疗、预防、缓解或诊断为目的。”这一类别包括化学药和生物制品。 在这一监管举措的变更下,HSA将在保健品法案下实施四套附属法例。这项立法将涵盖药品生产、注册、临床试验、供应、进口、广告、不良事件报告和执法措施。一些规定将在此过程中被更新。HSA已经宣布,它将计划在2015年的第三季度实施这些新法规,。 Read More
The developing world is experiencing more Western diseases as they consume more Western products such as fast food, leading to a rise in the cardiology, orthopedics, and cancer rates. This means that the developing world is seeing a growing demand for devices... Read More
For Class B, C, and D medical devices (see Classification of General Medical Devices in Singapore), there are two submission routes in Singapore: the abridged submission route and the full evaluation route. The abridged submission route is only for medical devices that... 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
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
亚洲人心脏衰竭发生的平均年龄在61岁 Read More
There is a wealth of opportunities for healthcare companies looking to expand to the Asian markets. This presentation provides an overview of important business and regulatory issues to consider for medical device companies interested in Asia. To view these presentation slides,... Read More
Economic growth in Asia will be almost 6% in 2014 (excluding Japan), compared with 1.5% in the EU and 2.5% in the U.S. Asia's growth will be led by China, which is expected to expand over 7% this year. The economies of... Read More