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China's Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration
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Published: Feb 2012 | Pages: 179 | Pub ID: MM1329822759 |
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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, in-vitro diagnostic reagents represented dynamical growth since 2007. By 2010, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 1.5 billion US dollars, an increase of 13.3% 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. The in-vitro diagnostic reagents have been widely used in the process of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and inherited disease prediction. It is estimated that Chinese in-vitro diagnostic reagent market is likely to be more than 20.8 billion RMB until 2015, and it is one of segment market of the most growth potentiality. The Chinese in-vitro diagnostic reagent market will attract more and more in-vitro diagnostic reagents produced by overseas manufacturers and producers to penetrate such market.
To enter such a lucrative in-vitro diagnostic reagent market, the first obstacle faced by overseas in-vitro diagnostic reagents manufacturers and producers is how to file the application for their imported in-vitro diagnostic reagent registration with Chinese regulatory authorities for in-vitro diagnostic reagents. In China, the process of application and approval for imported in-vitro diagnostic reagent registration is very complex, because the Chinese regulatory authorities for in-vitro diagnostic reagents 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 in-vitro diagnostic reagents manufacturers and producers. Therefore, a detailed guidance of practical operation for application and approval of imported in-vitro diagnostic reagent registration and a comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported in-vitro diagnostic reagent registration have been become an essential prerequisite for overseas in-vitro diagnostic reagents manufacturers and producers to achieve a successful application for their products entry into the Chinese in-vitro diagnostic reagent market. |
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| By: Access China |
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