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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

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
簡介

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。

第1章 摘要整理

第2章 中國的特別審查、符合認證次序的創新的醫療設備

第3章 進行海外的創新醫療設備的特別審查、認證的法規當局

第4章 對於海外的申請者的特別法規

第5章 海外的創新醫療設備應該準備申請文件一套

  • 表格:創新的醫療設備的特別審查、認證的申請書

第6章 特別審查、認證 海外的創新醫療設備的申請實踐的指導

  • 表格:特別審查、認證 對創新醫療設備的申請的審查通知書
  • 圖:創新的醫療設備的特別審查、認證手續的申請次序

第7章 創新的醫療設備的特別審查、認證的優點:次序的優先級和互動機制

  • 表格:「創新的醫療設備的傳遞信息及替換」的申請書
  • 表格:「創新的醫療設備的傳遞信息及替換」的申請的回饋信
  • 圖:創新的醫療設備的登記處理的優點:概要

第8章 總論

目錄
Product Code: ACMC2015010005PDF

Executive Summary

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.

Report Highlights

  • What innovative medical devices are applicable to Chinese special examination and approval procedures.
  • Who are the Chinese regulatory authorities for special examination and approval of overseas innovative medical devices?
  • The Chinese special regulations for overseas applicant.
  • How many application dossiers for an oversea innovative medical device should be prepared.
  • The detailed practical guidance for application of special examination and approval of overseas innovative medical devices to smoothly navigate complex regulatory requirements step by step.
  • What are the benefits from Special Examination and Approval of Innovative Medical Devices: Process Priority and Interactive Mechanism?
  • The significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval for overseas innovative medical devices.

Table of Contents

Contents

Chapter 1 - Executive Summary

Chapter 2 - What Innovative Medical Devices are Applicable to Chinese Special Examination and Approval Procedures

Chapter 3 - Who are Chinese Regulatory Authorities for Special Examination and Approval of Overseas Innovative Medical Devices?

Chapter 4 - Special Regulations for Overseas Applicant

Chapter 5 - How Many Application Dossiers for Oversea Innovative Medical Device should be Prepared

  • Table 1. Application Form for Special Examination and Approval of Innovative Medical Device

Chapter 6 - Practical Guidance for Application of Special Examination and Approval Overseas Innovative Medical Devices

  • Table 2. Notification Letter of Review on Application for Special Examination and Approval Innovative Medical Device
  • Figure 1. Application Steps for Special Examination and Approval Procedures of Innovative Medical Device

Chapter 7 - What are the benefits from Special Examination and Approval of Innovative Medical Devices: Process Priority and Interactive Mechanism?

  • Table 3. Application Form for Information Communication and Exchange of Innovative Medical Device
  • Table 4. Feedback Letter for Application of Information Communication and Exchange Innovative Medical Device
  • Figure 2. Overview of the Benefits for Processing of the Registration of an Innovative Medical Device

Chapter 8 - Conclusion

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