China Regulatory Framework for In-Vitro Diagnostic Reagents in New Report Available at

30 Sep 2014 • by Natalie Aster

LONDON – Presently, the Chinese regulatory framework for in-vitro diagnostic reagents is witnessing considerable changes. China’s new leaders have understood that the regulations for administration and supervision of in-vitro diagnostic reagents are far from perfect coupled with rapidly increasing population number and also thriving economy during the past 30 years. Therefore, a range of special regulation documents has been issued in China.

China is one of the most rapidly growing global economies; it ranks fifth in the world in terms of population number. The country boasts one of the biggest healthcare markets worldwide. Spurred by the stable economic growth, rapidly increasing and also aging population, the national healthcare market has seen positive growth at an average rate of over 16% since 1990s. In-vitro diagnostic reagents sector has experienced dynamical growth since 2007.

In 2012, the value of in-vitro reagents on China’s healthcare market increased by 22.9% and reached USD 3.5 billion. By 2015, it is poised to climb to around USD 5.5 billion. In-vitro diagnostic reagents represent the most promising market sector, having a huge growth potential.

Cutting-edge research study “Latest Chinese Guidebook for Application and Approval of Imported In-Vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)” prepared by Access China Management Consulting Ltd presents deep insights into the Chinese in-vitro diagnostic reagent sector. Besides, it gives a detailed analysis of radical change of the country’s regulations on in-vitro diagnostic reagents, reviews the latest applicable regulations, examines the organizational structure of the Chinese regulatory authorities for imported in-vitro diagnostics reagents and also sheds light on the country’s approach for approval and registration of in-vitro diagnostic reagents as well as lays the informational foundation for the practical operation. The study offers details on the reagent classification and naming principles, provides look at the in-vitro diagnostic reagents clinical trials in China, gives guidance for application, alteration registration and renewal registration of imported reagents.

Report Details:

Latest Chinese Guidebook for Application and Approval of Imported In-Vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)
Published: September, 2014 
Pages: 208
Price: US$ 1,495.00

Other Guidebooks by Access China Management Consulting:

More new research studies by the publisher can be found at Access China Management Consulting page.


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