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已获得中国食品药品监督管理局（CFDA）批准的药物，通常需要一年半的时间医生才可以给病人使用。为尽快让病人使用上已经批准的药物，一些制药公司开始在药物获得批准以前，就开始着手价格审批，招投标和医院上市的工作。中国的药品定价，是指医院进行的药品定价和药品采购。确定进口药品的价格与设定国产药物的价格，有所不同。 Read More

香港的医疗器械注册不是强制要求的。然而我公司认为，所有的医疗器械在香港的销售，应该立即注册自己的产品。 Read More

After a drug has been approved by the China Food and Drug Administration (CFDA), it can take another year and a half until the pharmaceutical product can actually be prescribed by a doctor. To shorten this process, some drug companies begin the... 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

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

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

Sourcing medical devices in Asia has become a common practice as more companies are taking advantage of the lower overhead, lower labor costs and increasing technical capabilities available in the Asian countries. Medical device companies can buy and manufacture a wide array... 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

On December 17, 2013, the China Food and Drug Administration (CFDA) announced a streamlined device registration renewal process that took effect on January 1. The updated process will reduce the burden of paperwork on manufacturers, result in faster renewal certification approvals and... Read More

2013年12月17日，中国国家食品药品监督管理总局 （CFDA）发布简化版医疗器械重新注册流程，该流程于2014年1月1日开始生效。更新后的流程将减小生产商方面的文书负担，加快认证更新的通过时间，从而让核准机关可更专注于产品上市后的监管和新产品认证。这一举措是食药监总局加强和简化医疗器械管理的系列步骤中的最新举动。 Read More