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CFDA: Chinese medical device market shows constant growth

14. April 2014

International exporters are still struggling with the slow recovery of the global economy, however emerging markets such as the People’s Republic of China have become an important stimulus for the world economy. As in previous years, China is again identified as the biggest driver of global economic growth. According to a publication of the Germany Trade & Invest (GTAI), a growth rate of 7.5% and 7.3% is estimated for 2014 and 2015 for China.

For the last several years the automotive and chemical industries have seen exponential growth, year after year. Within the last few years the medical technology industry has been showing similar growth potential. According to a statement of GTAI, the revenue of medical technology market in 2013 has increased by 25.9% to $34.1 billion (U.S. dollars). Furthermore, other forecasts of various institutions estimate similarly that the demand for medical devices of the Chinese market will continue to develop dynamically in the upcoming years. For 2015 it is predicted that the medical technology industry value will reach $53.7 billion (U.S. dollars is expected). The predictions are supported by the ever-growing demand for health care services, the increasing life expectancy of the population as well as higher incomes and the increased demand for health services in the less developed parts of China.

medical healthcare test

This market growth is also triggered by various measures put in place by the Chinese government. They set a huge focus on reforming the health care system, including an increased budget. The government will increase from the 2.8 trillion Renminbi (RMB) in 2012 to 8.0 trillion RMB for 2020. A large amount of this expenses will be invested in new hospitals.

These forecasts show, that the Chinese market will continue to remain one of the important markets for medical devices worldwide for years to come.

For manufacturers of medical devices it is important to check the specific certification requirements before deciding to sell their products in the Chinese market. Most products have to be certified by the China Food and Drug Administration (CFDA). This authority is in charge of regulations and controls of all medical products in China and it is subordinated by Chinese Ministry of Health (MOH).

The regulations and standards of CFDA-certification of medical devices are very similar to the international EC (European Commission) standards. An example would be GB 9706.1:2007 (Medical Electrical Equipment) which directly corresponds with EC 60601-1:1995. Nevertheless, requirements and demands of CFDA may highly differ from those of other countries. It is important to understand which GB-Standard (GB stands for Guobiao, Chinese for “National Standard”) the tests for CFDA-certification have to be performed. If there is no GB-Standard available the tests standards will be specified by an industry standard (also known as a “YY” standard). Changes in standards happen regularly, often without much advance notice, so it is important to check the relevant standards and regulations for CFDA certification regularly. We will continue to inform you on our website in our “News” section about published official announcements and more information regarding CFDA.


Please do not hesitate to contact us by phone (+49-69-2713769150) or email us if you have any further questions.

MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150