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

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

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

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

第8章 總論

Facing a gigantic population and rapid population aging, China's regulatory framework for medical devices is undergoing radical changes. In order to promote the implementation of a strategy of healthy China, transform the treating diseases as focal points into the people's health as centre, prevent and control the major diseases, actively respond to the aging of the population and accelerate the development of aged healthcare service to give the populace with a full range and full-cycle health and medical services for lifetime, the Chinese "National Medical Products Administration (NMPA)" issued the latest modified version of "Special Examination and Approval Procedures for Innovative Medical Devices" on November 2, 2018, and implemented on December 1, 2018. Its aim is to encourage research and innovation of medical devices, promote the popularization and application of new technologies for medical devices to finally meet the growing medical care needs.

Chinese special examination and approval procedures for innovative medical devices established a fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices, which reduces risk from the review uncertainty and approval delays that avoid to exhaust applicant's time and energy. This fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices offer a huge business opportunity for the foreign medical device manufacturers to achieve a successful entry into Chinese healthcare market and smoothly operate their business in China.

How to grasp the opportunity to speed up your innovative medical device product approval? The overseas and multinational medical device manufacturers must have a comprehensive knowledge of the Chinese special examination and approval procedures for innovative medical devices.The Chinese regulatory approach is unique.

"Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market" provided a comprehensive 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.

The organizations of this guidebook are arranged as follows. Chapter 2 introduces what innovative medical devices are applicable to Chinese special examination and approval procedures. Chapter 3 introduces who are the Chinese regulatory authorities for special examination and approval of overseas innovative medical devices. Chapter 4 elaborates the special regulations for overseas applicant. Chapter 5 introduces how many application dossiers for an oversea innovative medical device should be prepared. Chapter 6 provides the practical guidance for application of special examination and approval procedures of overseas innovative medical devices. Chapter 7 elaborates the benefits from special examination and approval procedures of innovative medical devices: priority processing and interactive mechanism. Chapter 8 conclusions give significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval procedures for overseas innovative medical devices. Chapter 9 appendices provide a full set of the English and Chinese bilingual forms relating to the overseas applicant applying for special examination and approval procedures of overseas imported innovative medical device and information communication and exchange of overseas imported innovative medical device with the Chinese drug regulatory authorities, and the feedback letter from the Chinese drug regulatory authorities.

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China and how to comply with the latest Chinese regulations for medical device registration.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive knowledge of the latest Chinese special examination and approval of overseas innovative medical devices but also the practical operation how to comply with the latest Chinese special examination and approval of overseas innovative medical devices. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market and smoothly operate their products in China.

Table of 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

• 5.1. Content Requirements for Application Materials
• 5.2. Format Requirements for Application Materials
• 5.3 Other Special Requirements for Application Materials

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

• Figure 1 Application Process for Special Examination and Approval Procedures of Overseas Imported Innovative Medical Device
• Figure 2 Application Process for Communication and Exchange of Overseas Imported Innovative Medical Device

Chapter 7 What are the benefits from Special Examination and Approval Procedures of Innovative Medical Devices: Priority Processing and Interactive Mechanism

• Figure 3. Overview of the Benefits of Special Examination and Approval Procedures for Overseas Imported Innovative Medical Devices

Chapter 8 Conclusion: Sincere Advice

Chapter 9 Appendices

• Annex 1 Application Form for Special Examination and Approval of Innovative Medical Device
• Annex 2 Application Form for Information Communication and Exchange of Innovative Medical Device
• Annex 3 Feedback Letter for Application of Information Communication and Exchange of Innovative Medical Device

List of Tables

• Annex 1 Application Form for Special Examination and Approval of Innovative Medical Device
• Annex 2 Application Form for Information Communication and Exchange of Innovative Medical Device
• Annex 3 Feedback Letter for Application of Information Communication and Exchange of Innovative Medical Device

List of Figures

• Figure 1 Application Process for Special Examination and Approval Procedures of Overseas Imported Innovative Medical Device
• Figure 2 Application Process for Communication and Exchange of Overseas Imported Innovative Medical Device
• Figure 3. Overview of the Benefits of Special Examination and Approval Procedures for Overseas Imported Innovative Medical Devices