Home
About Us|Market Research|Research Report|Report Store|International Trade|Strategic Investment|Contact Us
Report Store
Published Date: February 2014
Page Count: 34
Unit Price: US$ 750
Site License: US$3500
Global License: US$ 5,250
Format: Electronic PDF copy



Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition)

Summary Table of contents

How to handle a medical device recall smoothly in China? When is recall reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? How to comply with Chinese medical device recall regulations? 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 regulations for medical device recall. Otherwise the overseas and multinational medical device manufacturers and their imported medical devices will lose a lucrative medical device market. 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 and producers.

Latest Guidebook for Chinese Medical Device Recall Regulations (2014Edition is an essential resource for overseas and multinational medical device manufacturers and producers to handle a medical device recall smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese medical device recall regulations.

 

The audiences of this guidebook are overseas medical device companies 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 the latest Chinese Medical Device Recall Regulations. After have skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese 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 and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their companies in China.

 

Report Highlights

 

l        An overview of organizational structure of Chinese Regulatory Authorities for Medical Device Recall.

l        Chinese general regulations for medical device recall, which cover the definitions relating to medical device recall,  the answers of who, where and how to submit medical device recall report, the investigation and evaluation of medical device defects, as well as the classification for medical device recall.

l        Detailed Chinese regulations for voluntary recall of medical devices, from the time limits of notifying, the indispensable content of the recall notification and the investigation and evaluation report, the recall plan, the periodically reporting and summary report to termination of recall.

l        An entire process of voluntary recall of medical devices to guide you to successfully navigate complex regulatory requirements step by step.

l        Detailed Chinese regulations for mandatory recall of medical device, tell you how would trigger a mandatory recall of medical device, 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.

l        An entire process of mandatory recall of medical device to guide you to smoothly navigate complex regulatory requirements step by step.

l        A case study of recall of imported medical device from a U.S. company to expose practical operation.

l         A full set of the English and Chinese bilingual forms relating to medical device recall.

Need more information?
Call us or email us!
Tel:(86)25-85337409
E-mail:zengxian.wu@gmail.com
Home
About Us
Market Research
Research Report
Report Store
International Trade
Strategic Investment
Contact Us
Copyright © 2007-2017 Access China. All rights reserved.   ICP12078369-1   Privacy / Terms and conditions