Welcome to industryreportstore.com

Need help? +44(0)20 7936 6830

Regulation market research, reports and industry analysis

mail

Contact us for professional industry advice

Email us or call

+44(0)20 7936 6830
mail

for FREE research alerts
to your inbox

10 Item(s)

Page 1 of 1

  1. Latest Guidebook for Chinese Medical Device GMP Regulations

    By: Access China Management Consulting Ltd
    , Published: Nov-2015
    , Product code: ACMC201511003
    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 as well as an ageing population, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2014, total value of medical devices on Chinese healthcare market has reached 255.6 billion RMB (about 40.25 billion US dollars). Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. On the Chinese medical device market, imported overseas medical devices made by overseas and multinational medical device manufacturers account for about a half, in which the high-tech and high-valued medical devices, such as magnetic resonance imaging (MRI) equipments, computed tomography (CT) equipments are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 53.15 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States. Undoubtedly, China has an indispensable medical device market for overseas and multinational medical device companies. It’s definitely a field worth playing on.
    $1,495.00

  2. Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market

    By: Access China Management Consulting Ltd
    , Published: Jan-2015
    , Product code: ACMC201501005
    Chinese regulatory authorities ---- China Food and Drug Administration unprecedentedly set a special examination and approval procedures for innovative medical devices since March 1, 2014, which provides a opportunity to speed up overseas innovative medical devices entry into Chinese market, and reduce risk from the registration examination uncertainty and approval delays to eat up your time and energy. Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market provided a comprehensive and thorough knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations.
    $750.00

  3. Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)

    By: Access China Management Consulting Ltd
    , Published: Nov-2014
    , Product code: ACMC201411008
    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.
    $1,250.00

  4. Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)

    By: Access China Management Consulting Ltd
    , Published: Oct-2014
    , Product code: ACMC20141009
    China’s regulatory framework for medical devices is undergoing radical changes. The country’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, which has come into force as of June 1, 2014. Before long, China Food and Drug Administration (hereafter called as CFDA) issued the latest “Measures for the Administration of Medical Device Registration”, which has come into force as of October 1, 2014.The overseas medical devices exporting into China market are subject to administration of overall new regulations on medical device registration since October 1, 2014.
    $1,495.00

  5. Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)

    By: Access China Management Consulting Ltd
    , Published: Sep-2014
    , Product code: ACMC201409028
    China’s regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. It will bring overseas and multinational in-vitro diagnostic reagent manufacturers the maximum challenges and opportunities. How do you in compliance with the latest Chinese regulations on in-vitro diagnostic reagents? How do you operate business smoothly in China? To enter such a lucrative in-vitro diagnostic reagent market, overseas and multinational in-vitro diagnostic reagent manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on in-vitro diagnostic reagent registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative in-vitro diagnostic reagent market, and cause trouble for your business smoothly in China.
    $1,495.00

  6. Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)

    By: Access China Management Consulting Ltd
    , Published: Aug-2014
    , Product code: ACMC201408008
    Now, Chinese regulations on medical devices are undergoing earthshaking changes. Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration?From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations for imported medical device registration but also introduced the practical operation how to comply with the Chinese regulations to guide you achieve a successful approval for your products entry into the Chinese medical device market.
    $1,250.00

  7. Latest Guidebook for Conducting Medical Device Clinical Trials in China: From Regulations to Practices (2014 Edition)

    By: Access China Management Consulting Ltd
    , Published: Aug-2014
    , Product code: ACMC201408004
    Latest Guidebook for Conducting Medical Device Clinical Trials in China: From Regulations to Practices (2014 Edition) guide overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs to use the Chinese trial venues to keep medical device development lean and achieve a successful approval for their products entry into the Chinese medical device market, from a comprehensive and thorough knowledge of the latest Chinese laws and regulations on clinical trials for imported medical device registration to the practical operation how to comply with the Chinese GCP .
    $750.00

  8. China’s Guidebook for Application and Approval of Imported Medical Device Registration (2013 Edition)

    By: Access China Management Consulting Ltd
    , Published: Mar-2014
    , Product code: ACMC 201302003-
    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. On the Chinese medical device market, imported medical devices made by overseas and multinational medical device manufacturers account for about a half, in which the high-tech and high-valued medical devices, such as magnetic resonance imaging, CT are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. 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.
    $750.00

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

    By: Access China Management Consulting Ltd
    , Published: Feb-2014
    , Product code: ACMC20140204-
    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.
    $750.00

  10. Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market

    By: GBI Research
    , Published: May-2013
    , Product code: GBIME0078MR-
    GBI Research’s report “Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market” looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices. The report provides comprehensive information on establishment registration, medical device listing, Premarket Notification (510k) or Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies, Quality System (QS) regulation, labeling requirements, and Medical Device Reporting (MDR). The report also reviews the reimbursement scenario in these medical device markets. It is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.
    $3,500.00

10 Item(s)

Page 1 of 1