Latest Chinese Guidebook for Application and Approval of Imported in-Vitro Diagnostic Reagent Registration: from Regulations to Practices

Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices

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ResearchBeam adds a report titled "Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices". The report provides an in-depth study on the Imported In-vitro Diagnostic Reagent Registration Industry trends, opportunities and factors influencing the market.


China’s regulatory framework for in-vitro diagnostic reagents is undergoing earth-shaking changes. The country’s new leaders have recognized that the regulations for supervision and administration of in-vitro diagnostic reagents 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 June 1, 2014. Before long, China Food and Drug Administration issued a series of the latest regulations on in-vitro diagnostic reagents on July 30, 2014 respectively, and they will come into force as October 1, 2014. The overseas in-vitro diagnostic reagents exporting into China market will be subject to administration of overall new regulations on in-vitro diagnostic reagent registration since October 1, 2014.

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, in-vitro diagnostic reagents represented dynamical growth since 2007. By 2013, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 3.5 billion US dollars, an increase of 22.9% over 2012 level. It is estimated that Chinese in-vitro diagnostic reagent...