China Regulatory Environment for Innovative Medical Devices Discussed in Access China Management Consulting Study Available at MarketPublishers.com

06 Feb 2015 • by Natalie Aster

LONDON – China’s healthcare market has posted an average growth rate of more than 16% annually since the 1990s, underpinned by sustained economic growth and population explosion as well as an ageing population. Amid them, the medical devices sector witnessed fast-paced growth since the 2000s. By 2013-end, the medical devices sector within the country’s healthcare market was valued at more than USD 28.6 billion. Medical devices have been broadly utilised in the course of disease diagnosis, prevention, therapy, care and aftercare. In the domestic medical device market, imported foreign medical devices produced by overseas and transnational manufacturers account for nearly 50% of the total market, in which the high-valued and high-end medical devices, such as magnetic resonance imaging (MRI) and computed tomography (CT) are practically monopolised by Siemens, GE, Philips and other companies. Forecasts suggest the Chinese medical device market be worth around USD 54.4 billion by 2015-end and become the 2nd largest medical device market after the USA. 

Topical study “Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market” created by Access China Management Consulting Ltd provides a 360-degree analysis of the latest Chinese special examination and approval procedures for innovative medical devices to assist overseas and transnational medical device producers in performing practical operation along the lines of the regulations in the country.

The report scrutinises the innovative medical products that are applicable to China’s special examination and approval procedures, limelights the regulatory bodies for special examination and approval of foreign-made innovative medical equipment and devices, the nation’s special regulations for foreign applicants,  the required number of application dossiers for an oversea novel medical device, a comprehensive guidance for application of special examination and approval of overseas novel medical devices to safely navigate complicated legal and regulatory requirements stepwise, looks into the advantages of special examination and approval of innovative medical products interactive mechanism and process priority.

Report Details:

Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market 
Published: January, 2015
Pages: 32 
Price: US$ 750.00

More topical reports by the publisher can be found at Access China Management Consulting page.

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