SYS-CON MEDIA Authors: Carmen Gonzalez, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

News Feed Item

Latest Guidebook for Chinese Medical Device Recall Regulations

MUMBAI, February 6, 2014 /PRNewswire/ --

Bharat Book Bureau presents Latest guidebook for Chinese Medical Device Recall Regulations 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.  (http://www.bharatbook.com/medical-devices-market-research-reports/latest-guidebook-for-chinese-medical-device-recall-regulations.html)

China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare market has reached 179 billion RMB. Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation.

It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB by 2015, and will surpass Japan to become the second largest medical device market following the United States. The Chinese medical device market will attract more and more overseas medical device manufacturers and producers to penetrate such market.

If you search on website of the Chinese regulatory authority of medical devices, China Food and Drug Administration, you may find there are many announcements of medical devices recall for those that made by overseas and multinational medical device manufacturers, because the imported medical devices account for about a half of Chinese medical device market, in which the high-tech and high-value medical devices, such as magnetic resonance imaging, CT are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies.

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.

Report Highlights

  • An overview of organizational structure of Chinese Regulatory Authorities for Medical Device Recall.
  • 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.
  • 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.
  • An entire process of voluntary recall of medical devices to guide you to successfully navigate complex regulatory requirements step by step.
  • 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.
  • An entire process of mandatory recall of medical device to guide you to smoothly navigate complex regulatory requirements step by step.
  • A case study of recall of imported medical device from a U.S. company to expose practical operation.
  • A full set of the English and Chinese bilingual forms relating to medical device recall.

After have skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Medical Device Recall Regulations.

Who should buy this report?

  • Overseas medical device companies wishing to enter into the Chinese medical device market.
  • Multinational medical device companies have penetrated into the Chinese medical device market.
  • Companies interested in understanding the latest Chinese Medical Device Recall Regulations.
  • Senior executive officers engaging in regulatory affairs for imported medical device into Chinese lucrative medical device market.

Request for sample pages:  http://www.bharatbook.com/RequestSample.asp?pid=467674

Table of Contents

  • Introduction
  • An Overview of Chinese Regulatory Authorities for Medical Device Recall.
  • General Regulations for Medical Device Recall
  • Voluntary Recall of Medical Devices
  • Mandatory Recall of Medical Devices.
  • Legal Liabilities
  • Remedy for Patient.
  • Case Study -U.S. Philips Medical Systems (Cleveland), Inc. Recall Single Photon Emission Computed Tomography System

For more information and complete table of contents:  http://www.bharatbook.com/medical-devices-market-research-reports/latest-guidebook-for-chinese-medical-device-recall-regulations.html

Related Reports:


Related Category:


About Bharat Book Bureau

Bharat Book Bureau is the leading market research information aggregator that provides market research reports, industry analysis, company profiles, business reports, country reports, newsletters and online databases. Our clients include Corporate, Consulting firms, and Academic Institutions and Government departments across the globe. Bharat Book Bureau provides over a million reports from more than 400 publishers around the globe. The market research reports we provide, help global companies examine the different markets before setting up a business or expanding into different countries across the world. They give a complete perspective on the current market scenario, trends, segments and future outlook.

Contact us:
Poonam
Bharat Book Bureau
USA/Canada - 1-866-279-8368 (Toll free)
India: +91-22-27810772, 27810773
Blog: http://blog.bharatbook.com
E: [email protected]
W: http://www.bharatbook.com


More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...
What do a firewall and a fortress have in common? They are no longer strong enough to protect the valuables housed inside. Like the walls of an old fortress, the cracks in the firewall are allowing the bad guys to slip in - unannounced and unnoticed. By the time these thieves get in, the damage is already done and the network is already compromised. Intellectual property is easily slipped out the back door leaving no trace of forced entry. If we want to reign in on these cybercriminals, it's hig...
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...