China is one of the fastest growing global economies with a fourth population in the world, and is one of the largest healthcare markets round the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, overseas imported medical devices represented dynamical growth since 2000s. By 2010, total value of overseas imported medical devices on Chinese healthcare market has reached 7.957 billion US dollars, an increase of 30.35% over 2009 level.
In 2009, the Chinese government vigorously launched “China’s Health-Care Reform”, developed an ambitious blueprint, in which health care system will cover about 1.2 billion people by 2011. Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. It is estimated that within the next few years, Chinese medical device market is likely to be more than 600 billion RMB, and will surpass Japan to become the second largest medical device market following the United States. The Chinese medical devices market will attract more and more medical devices produced by overseas manufacturers and producers to penetrate such market.
To enter Chinese lucrative medical device market, the first obstacle faced by overseas medical devices manufacturers and producers is how to file the application for their imported medical device registration with Chinese regulatory authorities for medical devices.
In China, the process of application and approval for imported medical device registration is very complex, because the Chinese regulatory authorities for medical devices administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency. Lack of knowledge of the Chinese laws and administrative regulations, and the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas medical devices manufacturers and producers. Therefore, a detailed guidance of practical operation for application and approval of imported medical device registration and a comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported medical device registration have been become an essential prerequisite for overseas medical devices manufacturers and producers to achieve a successful application for their products entry into the Chinese medical device market.
China’s Guidebook for Application and Approval of Imported Medical Device Registration is an essential resource for overseas medical devices manufacturers and producers to achieve a successful application for their products entry into the Chinese medical device market, which provides not only a detailed guidance of practical operation for application and approval of imported medical device registration but also comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported medical device registration to guide overseas medical devices manufacturers and producers step by step to pass through the entirely legal procedures of application and approval for imported medical device registration smoothly.
Who should buy this report?
SIMILAR MARKET STUDIES
Glucose Meter is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of home blood glucose monitoring (HBGM) by people with diabetes ...
September 2017 | $4880 | View Details >>
This report studies the Pet Insurance market, Pet insurance is a type of specialty property and casualty insurance policy that pet owners purchase to cover the unintended costs that arise in providing care for a pet, including veterinary services such as surgical procedures, injuries from accidents, and prescribed pet medicines. ...
September 2017 | $4880 | View Details >>
Geographically, this report is segmented into several key Regions, with production, consumption, revenue, market share and growth rate of Biofeedback Instrument in these regions, from 2012 to 2022 (forecast), covering North America Europe China Asia (Ex. China) RoW The major players in global Biofeedback Instrument market include Thought Technology Ltd Laborie Qxsubspace Vishee Quantum World Vision BrainMaster Technologies, Inc. Mind Media NeuroCare Allengers Medical Systems ELMIKO NCC ...
September 2017 | $2900 | View Details >>
This report studies the Irreversible Electroporation Ablators market status and outlook of global and major regions, from angles of players, regions, product types and end industries; this report analyzes the top players in global and major regions, and splits the Irreversible Electroporation Ablators market by product type and applications/end industries. The ...
September 2017 | $4000 | View Details >>
UPCOMING MARKET RESEARCH REPORTS
2017 © Copyright Big Market Research