Masterstudiengang "Drug Regulatory Affairs"
Medical Device Regulations in the People’s Republic of China - the New Trend and the Challenges and Opportunities to European Medical Device Manufacturers ***
Xinyu Meng (Abschlußjahr: 2019)
While being an attractive market to foreign medical device manufacturers, China is also considered to be one of the difficult markets due to the Chinese specific and rapidly changing regulations. Especially since the former State Food and Drug Administration (SFDA) reconstructed into the China Food and Drug Administration (CFDA) in 2013, the medical device regulations in China went through many changes, including major ones. In 2014, two fundamental regulations, the "Regulations for the Supervision and Administration of Medical Devices" and the "Provisions for Medical Device Registration" have been revised and came into force. Subsequently other regulations have been revised and new regulations and guidelines have been issued as well, providing clarifications to critical issues such as the requirement on clinical evaluations. The CFDA attempted to better normalize the review and approval procedures for medical device applications.
In March 2018 the CFDA has been reconstructed into the National Medical Products Administration (NMPA), which is now under the supervision of the State Administration for Market Regulation (SAMR). The post market surveillance of medical devices in China will be strengthened. New changes to the medical devices regulations in China are to be expected.
This master thesis took a general but systematic review of the current medical device regulations in China that have come into force since 2014, analysing the gap between the regulatory requirements in China and in the EU, with the focus on application procedures. This thesis also identified some of the most intriguing new trend in the recent changes of Chinese medical device regulations and discussed the possible challenges and opportunities to be faced by European medical device manufacturers that comply already with the medical device regulations in the EU. According to the author’s opinion, even though China will remain challenging to foreign manufacturers for quite some time, the recent changes of Chinese medical device regulations indicated positive signs of better normalized procedures. Although language could be an issue, as long as the foreign manufacturers manage the communication with their local agents effectively, it’s not impossible to keep up with the regulation changes in China. Besides, identifying the local specific requirements as early as possible will definitely be more helpful than trying to cover the gap later, which applies to any other markets as well.