How to Use Overseas Clinical Trial Data to Apply for Marketing Authorization in China?

In January 2018, predecessor of the National Medical Products Administration (NMPA), China Food and Drug Administration (CFDA) issued the “Technical Guideline for Accepting Overseas Clinical Trial Data of Medical Devices” to attempt speeding up marketing authorization approval for overseas medical devices in China. At present, National Medical Products Administration (NMPA) is firmly enforcing this Guideline. Indubitably, this is an opportunity that the foreign medical device manufacturers let their medical devices successful entry the Chinese healthcare market. However, the Guideline clearly stated that overseas clinical trial data should not only comply with the ethical principles, legal principles and scientific principles but also the China’s GCP for Medical Devices. The Guideline elaborated the Chinese Drug Regulatory Authority on the considering factors and technical requirements for accepting overseas clinical trial data from the aspects of technical review requirements, differences of trial population and clinical trial conditions. In fact, during in the process of granting marketing authorization approval for overseas medical devices in China, not only the overseas clinical trial data of medical devices submitted by the overseas medical device manufacturer should comply with the China’s GCP for Medical Devices, but also the overseas medical device manufacturer should designate an agency with legal person status within the territory of China or its representative office stationed in China to act as its agent to apply for communication and exchange with the Center for Medical Device Evaluation of NMPA (hereinafter called as CMDE).

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If the overseas medical device manufacturer can reach a consensus with the CMDE on overseas clinical trial data of medical devices submitted, then the overseas medical device manufacturer has got half the results for marketing authorization approval. All these efforts, however, must be established on base complying with the China’s GCP for Medical Devices and the considering factors and technical requirements for overseas clinical trial data by Chinese Drug Regulatory Authority. Chinese regulatory approach is unique, which is different from that of US-EU. Chinese Drug Regulatory Authority administers and controls over this procedure of granting marketing authorization approval for overseas medical devices by exorbitant administrative measures and complex regulations. Moreover, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas medical device manufacturers. As a result, in order to smoothly pass this procedure of granting marketing authorization approval by submitted the overseas clinical trial data of medical devices, the overseas medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of China’s GCP for Medical Devices.

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