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市場調查報告書
中國的創新醫療設備的特別審查、認證手續:海外的創新醫療設備的進入中國市場的迅速化Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market |
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| 出版商 | Access China Management Consulting | 商品編碼 | 323514 | ||||
| 出版日期 | 內容資訊 | 英文 32 Pages 商品交期: 最快1-2個工作天內 |
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| 中國的創新醫療設備的特別審查、認證手續:海外的創新醫療設備的進入中國市場的迅速化 Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market | ||
| 出版日期: 2015年01月28日 | 內容資訊: 英文 32 Pages |
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中國的醫療設備市場到2015年估計成長超過3,400億人民幣的規模，超過日本接著美國成為全球第2大醫療設備市場。因此中國對海外的醫療設備製造商來說是富有魅力的市場，但是國內非常複雜且欠缺透明度的進口醫療設備的登記、登記手續成為進入的障礙。可是2014年3月， 中國國家食品藥品監督管理局(CFDA)推進醫療設備的研究開發，圖謀新技術的引進及普及，為了與醫療設備產業的發展連接，整備創新的醫療設備的特別審查次序。以這個次序，迅速化到核准為止的手續，構築縮小不透明性的風險的互動機制。
接受本報告提供中國的創新醫療設備的特別審查次序相關的總括性調查、符合這個次序的創新醫療設備、法規當局、對於海外的申請者的特別法規概要、必要的申請文件、申請的實踐的指導、本核準的優點等彙整資料。
Now, China's regulatory framework for medical devices is undergoing radical changes. China one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an ageing population, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare market has reached 179 billion RMB. Medical devices have been widely used in the process disease prevention, diagnosis, therapy, care and rehabilitation. On the Chinese medical device market, imported overseas medical devices made by overseas and multinational medical device manufacturers account for about a half, in which the high-tech and high-valued medical devices, such as magnetic resonance imaging, CT are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB by 2015, and will surpass Japan to become the second largest medical device market behind the United States. The Chinese medical device market is attracting more and more overseas medical device manufacturers and producers to penetrate such market.
However, In China, the process of application and approval for imported overseas medical device registration is very complex, because the Chinese medical device authorities administer and control this process by exorbitant administrative regulations and measures. Moreover, these exorbitant administrative measures and regulations are variable and lack of transparency. addition, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational medical device manufacturers and producers.
Nonetheless along with radical changes of regulatory framework for medical devices, Chinese regulatory authorities ---- China Food and Drug Administration (hereafter called as CFDA) set special examination and approval procedures for innovative medical devices since March 2014 to encourage research and innovation of medical devices, promote the popularization and application of new technologies for medical devices, and promote the development of the medical device industry.
Chinese special examination and approval procedures for innovative medical devices established a fast-track approval path and an interactive mechanism between Chinese regulatory authorities and applicant for innovative medical devices, which reduce risk from the examination uncertainty and approval delays to eat up your time and energy so as to achieve a successful entry into such a lucrative medical device market, and to avoid trouble for your business smoothly in China.
How to grasp the opportunity to speed up your innovative medical device product approval time? The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the Chinese special examination and approval procedures for innovative medical devices.
‘Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market’ provided a comprehensive and thorough knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations.
