Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition)


News provided by

Bharat Book Bureau

18 Nov, 2014, 10:30 GMT

Share this article

Share toX

Share this article

Share toX

MUMBAI, November 18, 2014 /PRNewswire/ --

This report not only provides a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provides the guidance of practical operation for how to achieve a successful approval for your products entry into the Chinese medical device market.

Executive Summary  

The Chinese medical device market is one of segment market of the most growth potentiality, which is attracting more and more overseas medical device manufacturers and producers to penetrate such market. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 57 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States.

However, China's regulatory framework for medical devices is undergoing radical changes. China's new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest "Regulations for the Supervision and Administration of Medical Devices" on February 12, 2014, and it has come into force as of June 1, 2014. China Food and Drug Administration issued the latest "Measures for the Administration of Medical Device Registration", and it has come into force as of October 1, 2014. The overseas medical devices exporting into China market should be subject to administration of overall new regulations since October 1, 2014.

For Sample Page and Complete Table of Contents:  

https://www.bharatbook.com/medical-devices-market-research-reports-323891/guide-prepare-application-dossiers-device-registration-recordation-china.html

The Chinese administration system for medical device registration undergone significant changes. Chinese authorities have begun to strengthen the supervision and administration of its medical device market. To strictly examine and approve the application dossiers for oversea medical device registration in China has become as the key threshold of oversea medical device exporting into China. The Chinese approach to administer medical device registration is unique. The application and approval process, clinical evaluation and clinical trial, the requirements for application dossiers are distinct from in U.S. and EU countries. How do you in compliance 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 preparation of application dossiers compliance with overall new regulations becomes as the key for oversea medical device entry into 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.

Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition) not only provided a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provided the guidance of practical operation for how to achieve a successful approval for your products entry into the Chinese medical device market.

The organizations of this guidebook are arranged as follows.  

Chapter 2 provides a comprehensively comparative analysis to introduce what the Chinese regulations on medical device are undergoing radical changes.

Chapter 3 introduces the framework of the latest applicable Chinese regulations for medical device registration and recordation to provide a comprehensive and thorough knowledge of the latest Chinese regulations for medical device registration and recordation.

Chapter 4 elaborates the knowledge preparation before application of imported overseas medical device registration or recordation to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration or recordation and lay the knowledge foundation for the practical operation.

Chapter 5 introduces how many application dossiers for imported oversea medical device recordation should be prepared. 

Chapter 6 introduces the comprehensive and detailed requirements for application dossiers of imported oversea medical device recordation.

Chapter 7 introduces how many application dossiers for imported oversea medical device registration should be prepared.

Chapter 8 introduces the comprehensive and detailed requirements for application dossiers of imported oversea medical device registration.

Chapter 9 provides a list of basic requirements for safety and effectiveness of medical device product, which is overall new requirements for imported overseas medical device registration in China.

Chapter 10 elaborates the compilation of product technical requirements, which are also overall new requirements for imported overseas medical device registration in China.

Chapter 11 introduces how to apply for registration test of imported overseas medical device.

Chapter 12 elaborates the compilation of the instructions and labels of medical device.

Chapter 13 provides the practical guidance for conducting the unique clinical evaluation for imported overseas medical device registration in China to help overseas medical device manufacturers to remove their confusion.

Chapter 14 provides the practical guidance for conducting the clinical trials for imported overseas medical device registration in china, from what imported overseas medical devices need to conduct clinical trial and approval within Chinese territory, how to apply for clinical trial of imported medical device registration, how to compile application documents, how to select the clinical trial institutions and define every party's responsibilities in clinical trials to how to acquire the approval document for clinical trial of imported medical device registration to smoothly navigate complex regulatory requirements step by step.

Chapter 15 introduces the approval process for imported overseas medical device registration to guide overseas and multinational medical device manufacturers how to submit the application dossiers, ultimately achieve a successful approval for products entry into the Chinese medical device market.

Chapter 16 Appendices provide a complete set of full text in English of the latest Chinese regulations on medical devices, which over "Measures for the Administration of Medical Device Registration (2014Edition)", "Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)" "Rules for Medical Device Classification (2014Edition)", "Compiling Guidelines of Product Technical Requirements for Medical Devices" and "Technical Guidance Principles for Clinical Evaluation of Medical Devices.

Report Highlights

A comprehensively comparative analysis to introduce what the Chinese regulations on medical device are undergoing radical changes.

A framework of the latest Chinese applicable regulations for medical device registration and recordation to provide a comprehensive and thorough knowledge of the latest Chinese regulations for medical device registration and recordation.

The knowledge preparation before application of imported overseas medical device registration or recordation to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration or recordation and lay the knowledge foundation for the practical operation.

How many application dossiers for imported oversea medical device recordation should be prepared, and What are comprehensive and detailed requirements for application dossiers of imported oversea medical device recordation to guide the overseas and multinational medical device manufacturers to smoothly operate recordation for Class I imported oversea medical devices in China.

How many application dossiers for imported oversea medical device registration, what are comprehensive and detailed requirements for application dossiers of imported oversea medical device registration to guide the overseas and multinational medical device manufacturers to smoothly operate registration for Class II and III imported oversea medical devices in China.

A list of basic requirements for safety and effectiveness of medical device product to reveal latest requirements for imported overseas medical device registration in China.

How to compile product technical requirements to guide the overseas and multinational medical device manufacturers to company with another latest requirements for imported overseas medical device registration in China.

The practical guidance for conducting the unique and complicated clinical evaluation for imported overseas medical device registration in China to help overseas medical device manufacturers to remove their confusion.

The practical guidance for conducting the clinical trials for imported overseas medical device registration in china, from what imported overseas medical devices need to conduct clinical trial and approval within Chinese territory, how to apply for clinical trial of imported medical device registration, how to compile application documents, how to select the clinical trial institutions and define every party's responsibilities in clinical trials to how to acquire the approval document for clinical trial of imported medical device registration to smoothly navigate complex regulatory requirements step by step.

The approval process for imported overseas medical device registration to guide overseas and multinational medical device manufacturers how to submit the application dossiers, ultimately achieve a successful approval for products entry into the Chinese medical device market.

A complete set of full text in English of latest Chinese regulations on medical devices closely related to preparing application dossiers for imported overseas medical device registration and recordation, which cover "Measures for the Administration of Medical Device Registration (2014 Edition)", "Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)" "Rules for Medical Device Classification (2014Edition)", "Compiling Guidelines of Product Technical Requirements for Medical Devices" and "Technical Guidance Principles for Clinical Evaluation of Medical Devices".

Table of Content:   

- Chapter 1 Executive Summary

- Chapter 2 What Chinese Regulations on Medical Device are Undergoing Radical Changes ---- A Comprehensively Comparative Analysis

- Chapter 3 Latest Chinese Applicable Regulations for Medical Device Registration and Recordation

- Chapter 4 Knowledge Preparation of Preparing Application Dossiers for Imported Oversea Medical Device Registration or Recordation

- Chapter 5 How Many Application Dossiers for Imported Oversea Medical Device Recordation should be Prepared

- Chapter 6 Requirements for Application Dossiers of Imported Oversea Medical Device Recordation

- Chapter 7 How Many Application Dossiers for Imported Oversea Medical Device Registration should be Prepared

- Chapter 8 Requirements for Application Dossiers of Imported Oversea Medical Device Registration

- Chapter 9 List of Basic Requirements for Safety and Effectiveness of Medical Device Product

- Chapter 10 How to Compile the Product Technical Requirements

- Chapter 11 How to Apply for Registration Test

- Chapter 12 How to Compile the Instructions and Labels of Medical Devices

- Chapter 13 How to Conduct the Clinical Evaluation for Imported Overseas Medical Device Registration in China

- Chapter 14 How to Conduct the Clinical Trials of Imported Medical Device Registration in China

- Chapter 15 Submission of Application Dossiers and Approval Process

- Chapter 16 Appendices

Related Reports:  

- Medical Aesthetic Devices: Technologies and Global Markets 

- 2014 Deep Research Report on Global Medical Oxygen Concentrator Industry

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

- Saudi Arabia Medical Devices Report

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 Details:

Poonam

Bharat Book Bureau

USA/Canada - 1-866-279-8368 (Toll free)

India: +91-22-27810772, 27810773

Blog: https://www.bharatbook.com/blog/

E: poonam@bharatbook.com

W: http://www.bharatbook.com

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.