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印度将对医疗器械不良反应进行监测 Read More

India to Monitor Medical Device Adverse Events Read More

美国FDA药品监管新闻 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

In India, a medical device registration certificate (Form 41) is valid for 3 years from the date of issue. Applications for re-registration should be submitted 9 months before the registration certificate expires. Recently, the Indian government has been focusing more on post... Read More

On April 14, 2014, the Korean Ministry of Food and Drug Safety (MFDS) announced that it is planning to test random drug samples of products currently on the market, starting in June 2014. Both generic drugs and original drugs will be tested,... Read More

在印度，医疗器械注册证书（表格41）有效期为自签发之日起3年有效. 应在医疗器械注册证书到期9个月之前申请产品重新注册. 近日，印度政府更加注重上市后监督对重新登记的影响. 在印度上市后医疗器械不良事件，及其处理措施需要仔细记录. 最新的印度标签标准还要求企业提供1-800或免费电话号码队产品进行投诉. Read More

2014年4月14日，朝鲜食品药品安全部（MFDS）宣布，从2014年6月开始它计划随机抽查已上市药品的生物等效性。仿制药和原创药都在测试范围里。这项措施的目的是提高仿制药的市场在韩国的质量。 Read More

The Indian medical device market is worth about $4.3 billion dollars. It is expected to grow to about $12 billion dollars by 2022. More and more Western device companies are registering their products in India. For registration renewals, the DCGI is now... 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