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中国の医療機器リコール規制:最新ガイドブック

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

発行 Access China Management Consulting 商品コード 295028
出版日 ページ情報 英文 44 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=109.32円で換算しております。
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中国の医療機器リコール規制:最新ガイドブック Latest guidebook for Chinese Medical Device Recall Regulations (2019 Edition)
出版日: 2019年02月28日 ページ情報: 英文 44 Pages
概要

医療機器に対する中国の規制の枠組みは、人口の増加と急速な高齢化に直面し、根本的な変化を遂げています。

当レポートでは、中国の医療機器リコール規制について調査分析し、最新のガイダンスについて、体系的な情報を提供しています。

第1章 イントロダクション

第2章 医療機器リコールに対する中国の規制当局の概要

第3章 海外の医療機器メーカーに対する中国の特殊規制

第4章 医療機器リコールに対する一般規制

  • 定義
  • リコールの方法
  • 調査と評価
  • 分類
  • リコールの公表

第5章 医療機器の自主リコール

  • 自主リコール
  • 自主リコールの全過程

第6章 医療機器の強制リコール

  • 強制リコール
  • 強制リコールの全過程

第7章 法的責任

第8章 患者の治療法

第9章 ケーススタディ

  • ケース1
  • ケース2

第10章 付録

目次
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.
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