表紙
市場調查報告書

中國的醫療設備回收法規:最新旅遊指南

Latest guidebook for Chinese Medical Device Recall Regulations (2019 Edition)

出版商 Access China Management Consulting 商品編碼 295028
出版日期 內容資訊 英文 44 Pages
商品交期: 最快1-2個工作天內
價格
中國的醫療設備回收法規:最新旅遊指南 Latest guidebook for Chinese Medical Device Recall Regulations (2019 Edition)
出版日期: 2019年02月28日內容資訊: 英文 44 Pages
簡介

中國對醫療設備的法律規範,面臨人口的增加迅速的高齡化,達成根本性變化。

本報告提供中國的醫療設備回收相關法規相關調查分析,最新的指導相關的系統性資訊。

第1章 簡介

第2章 中國對醫療設備回收的法規當局概要

第3章 中國對海外的醫療設備廠商的特殊法規

第4章 對醫療設備回收的一般法規

  • 定義
  • 回收的方法
  • 調查與評估
  • 分類
  • 回收的公佈

第5章 醫療設備的自主回收

  • 自主回收
  • 自主回收的全過程

第6章 醫療設備的強制回收

  • 強制回收
  • 強制回收的全過程

第7章 法律責任

第8章 患者的治療方法

第9章 案例研究

  • 案例1
  • 案例2

第10章 附錄

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: ACMC20190400102

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 government, on one side, accelerated the priority approval of innovative medical devices and relaxed the market access for overseas medical devices, on other side, intensified the supervision and administration for medical devices on the post-market. In China, today medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. However, large and medium-sized medical devices, high-end medical equipments and high-value medical materials are mainly relying on imported, such as the high-tech and high-valued imaging systems and navigation and positioning systems. In which the high-end and high-value medical devices are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. If you search on website of the Chinese regulatory authority--“National Medical Products Administration (NMPA)”, you may find there are many announcements of medical devices recall for those that made by overseas and multinational medical device manufacturers, because the overseas imported medical devices account for about half of the high-tech and high-valued products in Chinese medical device market. In order to meet the growing medical needs and ensure the safety of the people, the predecessor of the National Medical Products Administration (NMPA), China Food and Drug Administration (CFDA) issued the latest modified version of “Administrative Measures on Medical Device Recall” on January 25, 2017, which has been implemented on May 1, 2017. At present, National Medical Products Administration (NMPA) is firmly enforcing the “Administrative Measures on Medical Device Recall”. How do the overseas medical device manufacturers handle an overseas imported medical device recall smoothly in China? When is recall reporting voluntary vs. mandatory? What are characteristics and strategy of the recall that the overseas medical device manufacturers must consider when making the recall determination? How do the overseas medical device manufacturers comply with the Chinese latest medical device recall regulations? How do the overseas medical device manufacturers operate business smoothly in China? The overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese latest regulations on medical device recall. Otherwise the overseas and multinational medical device manufacturers and their imported medical devices would lose a huge medical device market in China. The regulations on medical device recall between China and US-EU are different. Moreover, 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.

Latest guidebook for Chinese Medical Device Recall Regulations (2019 Edition) is an essential resource for overseas and multinational medical device manufacturers to handle a medical device recall smoothly in China, which provides not only a comprehensive knowledge of the Chinese latest medical device recall regulations, but also a detailed practical guidance for the overseas and multinational medical device manufacturers to handle an overseas imported medical device recall smoothly in China.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the organizational structure of Chinese regulatory authorities for medical device recall. Chapter 3 provides the Chinese special regulations for overseas medical device manufacturers. Chapter 4 provides the general regulations for medical device recall, which cover the definitions relating to medical device recall, the practical guidance for who, where and how to submit medical device recall report, the investigation and evaluation of medical device defects, the classification for medical device recall, as well as information release for recalled medical device. Chapter 5 introduces the detailed regulations for voluntary recall of medical device, from the time limits of recall notifying, the indispensable content of the recall notification, the investigation and evaluation report, the recall plan, the periodical recall implementation report, disposal of recalled medical device to the recall summary report for terminating recall to guide you smoothly complete the recall, as well as a panoramic view of entire process of voluntary recall of medical device to let you understand at a glance. Chapter 6 elaborates the mandatory recall of medical device, which covering how would trigger a mandatory recall of medical device, what the contents of recall order issued by the drug regulatory authorities will be contained, how the medical device manufacturer copes with a mandatory recall of medical device, and how to handle a mandatory recall of medical device smoothly in China, as well as a panoramic view of entire process of mandatory recall of medical device exhibited also to let you understand at a glance. Chapter 7 introduces the detailed legal liabilities for the medical device manufacturers, the marketing or distributing enterprises and the user facilities of medical devices, and the drug regulatory authorities and their staff for a medical device recall. Chapter 8 introduces the remedy for patient. Chapter 9 introduces two typical cases of overseas imported medical device recall to expose practical operation. Chapter 10 provides a full set of the English and Chinese bilingual forms that are stipulated by the National Medical Products Administration (NMPA) to facilitate for you to operate them.

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device manufacturers have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand the Chinese latest medical device recall regulations. After have skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the Chinese latest medical device recall regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers to achieve a successful entry into the Chinese medical device market, and smoothly operate their business in China.

Table of Contents

Content

Chapter 1: Introduction

Chapter 2: An Overview of Chinese Regulatory Authorities for Medical Device Recall

  • Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device Recall

Chapter 3: Chinese Special Regulations for Overseas Medical Device Manufacturers

Chapter 4: General Regulations for Medical Device Recall

  • 4.1. Definitions
  • 4.2. Who, Where and How to Submit Medical Device Recall Report?
  • 4.3. Investigation and Evaluation of Medical Device Defects
  • 4.4. Classification for Medical Device Recall
  • 4.5. Information Release for Recalled Medical Device

Chapter 5: Voluntary Recall of Medical Device

  • 5.1. Voluntary Recall of Medical Device
  • 5.2. Entire Process of Voluntary Recall of Medical Device
    • Figure 5.2. An Entire Process of Voluntary Recall of Medical Device

Chapter 6: Mandatory Recall of Medical Device

  • 6.1. Mandatory Recall of Medical Device
  • 6.2. Entire Process of Mandatory Recall of Medical Device
    • Figure 6.2. An Entire Process of Mandatory Recall of Medical Device

Chapter 7: Legal Liabilities

Chapter 8: Remedy for Patients

Chapter 9: Case Study

  • Case 1: GE Ultrasound Korea Ltd. Voluntarily Recalls Color Ultrasound Diagnostic Apparatus
  • Case 2: Medtronic Navigation Inc. Changes Recall Corrective Actions and Quantity for Surgical Navigation Systems and Brain Surgery Navigation System

Chapter 10: Appendices

  • 10.1. Annex 1. Medical Device Recall Event Report Form
  • 10.2. Annex 2.Recall Program Implementation Report

List of Tables

  • Annex 1. Medical Device Recall Event Report Form
  • Annex 2.Recall Program Implementation Report Form

List of Figures

  • Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device Recall
  • Figure 5.2. An Entire Process of Voluntary Recall of Medical Device
  • Figure 6.2. An Entire Process of Mandatory Recall of Medical Device

Companies Mentionned:

  • GE Ultrasound Korea Ltd.
  • GE Medical Systems Trade & Development (Shanghai) Co. Ltd.
  • Medtronic Navigation Inc.
  • Medtronic (Shanghai) Management Co. Ltd.