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中国における革新的医療機器の特別審査・認証手続き:海外の革新的医療機器の中国市場への参入の迅速化

Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market

発行 Access China Management Consulting 商品コード 323514
出版日 ページ情報 英文 32 Pages
納期: 即日から翌営業日
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中国における革新的医療機器の特別審査・認証手続き:海外の革新的医療機器の中国市場への参入の迅速化 Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market
出版日: 2015年01月28日 ページ情報: 英文 32 Pages
概要

中国の医療機器市場は2015年までに3,400億人民元を超える規模に成長すると推計されており、日本を抜いて米国に次ぐ世界第2位の医療機器市場となる見込みです。このため海外の医療機器製造業者にとって中国は非常に魅力的な市場であるものの、同国の非常に複雑かつ透明性に欠けた輸入医療機器の登録・登記手続きが参入の障壁となっています。しかし2014年3月、中国国家食品薬品監督管理総局(CFDA)は医療機器の研究開発を推進し、新技術の導入および普及を図り、医療機器産業の発展につなげるため、革新的な医療機器の特別審査手順を整備しました。この手順では、承認までの手続きを迅速化し、不透明性から来るリスクを縮小するインタラクティブメカニズムが構築されています。

当レポートでは、中国における革新的医療機器の特別審査手順について包括的に調査し、当手順に該当する革新的医療機器、規制当局、海外の申請者に対する特別規制の概要、必要とされる申請書類、申請の実践的ガイダンス、本承認を受けるメリットなどをまとめています。

第1章 エグゼクティブサマリー

第2章 中国の特別審査・認証手順に該当する革新的医療機器

第3章 海外の革新的医療機器の特別審査・認証を行う規制当局

第4章 海外の申請者に対する特別規制

第5章 海外の革新的医療機器の用意すべき申請書類一式

  • 表:革新的医療機器の特別審査・認証の申請書

第6章 特別審査・認証 海外の革新的医療機器の申請の実践的ガイダンス

  • 表:特別審査・認証 革新的医療機器の申請に対する審査通知書
  • 図:革新的医療機器の特別審査・認証手続きの申請手順

第7章 革新的医療機器の特別審査・認証のメリット:手順の優先度とインタラクティブメカニズム

  • 表:「革新的医療機器の情報伝達および交換」の申請書
  • 表:「革新的医療機器の情報伝達および交換」の申請のフィードバックレター
  • 図:革新的医療機器の登録処理のメリット:概要

第8章 総論

目次
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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