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

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