Welcome!

News Feed Item

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices

MUMBAI, India, September 3, 2014 /PRNewswire/ --

Now, Chinese regulations on medical devices are undergoing earthshaking changes. China's new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid economic and population growth over the past three decades. Chinese state council issued the latest "Regulations for the Supervision and Administration of Medical Devices" to try to completely change such imperfect status. China Food and Drug Administration issued the latest "Measures for the Administration of Medical Device Registration", "Regulations on the Administration of the Instructions and Labels of Medical Devices", "Measures for the Supervision and Administration of Medical Device Production", "Measures for the Supervision and Administration of Medical Device Distribution" and "Measures for the Administration of IVD registration" on July 30, 2014 respectively, and they will come into force on October 1, 2014. The radical change of regulations on medical devices, especially for the latest "Measures for the Administration of Medical Device Registration" will bring overseas and multinational medical device manufacturers the maximum challenges and opportunities.

     (Logo: http://photos.prnewswire.com/prnh/20130128/590935 )

Those medical devices that have not been granted the certificate of marketing authorization of medical devices by the government authorities of the country or region of origin will be intercepted outside the door of Chinese medical device market. How do you comply with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How to seize a bigger Chinese medical device market? The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative medical device market, and cause trouble for your business smoothly in China.

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition) not only provides a comprehensive and thorough knowledge of the latest Chinese regulations for imported medical device registration but also introduces the practical operation of how to comply with the Chinese regulations to guide you to achieve a successful approval for your products entry into the Chinese medical device market.

For Sample Pages and Table of Contents: 

https://www.bharatbook.com/medical-devices-market-research-reports-228172/guidebook-application-approval-medical-device-registration-regulations.html

The organizations of this guidebook are arranged as follows. 

  • Chapter 2 provides the analysis and research for radical change of Chinese regulations on medical devices.
  • Chapter 3 Introduces the framework of the latest applicable Chinese regulations for medical device registration to provide a comprehensive and thorough knowledge of the latest Chinese regulations for medical device registration.
  • Chapter 4 provides an overview of the Chinese regulatory authorities -- China Food and Drug Administration (CFDA) being responsible for application and approval for imported overseas medical device registration and recordation to give the direction of gateway for imported overseas medical devices registration and recordation.
  • Chapter 5 elaborates on the knowledge preparation before application of imported overseas medical device registration to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration and lay the knowledge foundation for the practical operation.
  • Chapter 6 elaborates on the medical device classification to let overseas medical device manufacturer understand the Chinese medical device classification, because the imported overseas medical device registration must be in compliance with such classification of medical devices.
  • Chapter 7 introduces the rights of human subjects and every party's responsibilities in clinical trials for imported overseas medical devices in China.
  • Chapter 8 introduces the regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices.
  • Chapter 9 provides the regulations for application and approval for imported medical device registration, which is applicable to Class II and II imported overseas medical devices.
  • Chapter 10 introduces the regulations for application and approval for alteration registration of imported overseas medical devices.
  • Chapter 11 introduces the regulations for renewal registration of imported overseas medical devices.
  • Chapter 12 introduces the regulations for supervision and administration for application and approval of imported overseas medical device registration.
  • Chapter 13 provides the practical guidance for application of imported overseas medical device recordation, from how to compile recordation documents, how to apply for recordation to how to handle alteration recordation to smoothly navigate complex regulatory requirements step by step.
  • Chapter 14 provides the practical guidance for application and approval of imported overseas medical device registration, from how to compile application documents, how to conduct clinical trials for imported overseas medical devices to the application for approval of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.
  • Chapter 15 provides the practical guidance for alteration registration and renewal registration of imported overseas medical devices, also from

Report Highlights 

  • An overview of the latest Chinese applicable regulations for imported overseas medical device registration and recordation.
  • What Chinese regulations on medical devices are undergoing earthshaking changes? An overview of organizational structure of Chinese regulatory authorities for imported medical device registration and recordation to give the direction of gateway for imported medical device registration and recordation.
  • The knowledge preparation before application of imported overseas medical device registration and recordation to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration and lay the knowledge foundation for the practical operation.
  • The latest Chinese regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices.
  • The latest Chinese regulations for application and approval for imported medical device registration, which is applicable to Class II and II imported overseas medical devices.
  • The detailed Chinese medical device classification.
  • The rights of human subjects and every party's responsibilities in clinical trials for imported overseas medical devices in China.
  • The practical guidance for application of imported overseas medical device recordation, from how to compile recordation documents, how to apply for recordation to how to handle alteration recordation to smoothly navigate complex regulatory requirements step by step. z The practical guidance for application and approval of imported overseas medical device registration, also from how to compile application documents, how to conduct clinical trials for imported overseas medical devices to the application for approval of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.
  • The practical guidance for alteration registration and renewal registration of imported overseas medical devices, also from how to compile application documents to how to submit application documents step by step.
  • A complete set of full text in English of latest Chinese involving with the imported overseas medical device registration and recordation, which cover "Regulations for the Supervision and Administration of Medical Devices (2014 Edition)", "Measures for the Administration of Medical Device Registration(2014 Edition)", "Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)", "Provisions for Clinical Trials of Medical Devices", and "Rules for Medical Device Classification".

Related Categories: 

- Healthcare

- Medical Device

- Chinese Guidebook

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


SOURCE Bharat Book Bureau

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
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
We are always online. We access our data, our finances, work, and various services on the Internet. But we live in a congested world of information in which the roads were built two decades ago. The quest for better, faster Internet routing has been around for a decade, but nobody solved this problem. We’ve seen band-aid approaches like CDNs that attack a niche's slice of static content part of the Internet, but that’s it. It does not address the dynamic services-based Internet of today. It does...
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
"Qosmos has launched L7Viewer, a network traffic analysis tool, so it analyzes all the traffic between the virtual machine and the data center and the virtual machine and the external world," stated Sebastien Synold, Product Line Manager at Qosmos, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"We are a modern development application platform and we have a suite of products that allow you to application release automation, we do version control, and we do application life cycle management," explained Flint Brenton, CEO of CollabNet, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...