Breakthrough medical device policy and products in China

On September 3, 2022, China’s National Healthcare Security Administration issued a document mentioning that, it was clear that breakthrough consumables would not be included in the centralized procurement. 

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It was pointed that efforts should be made to improve the mechanism to reduce business costs and to enable new medical devices to be smoothly traded. To establish a market-led price formation mechanism that reflects the value of the product and the relationship between supply and demand, as well as taking into account factors such as the price of its similar medical devices, clinical efficacy, health benefits and the use of si​milar products internationally, so as to form a reasonable price for breakthrough medical device. 

​​For breakthrough medical device, as the clinical use is not yet mature, and the usage is difficult to predict for the time being. It is necessary to set aside a certain market outside the centralized procurement to provide space for breakthrough products.

What is the breakthrough medical device?

1.    The applicant, through its leading technological innovation activities, owns the patent right for the core technology of the product in China according to law, or obtains the patent right for the invention in China or the right to use the invention in China through transfer according to law, and the time of application for the special examination of the breakthrough medical device is not more than five years from the date of the announcement of the authorization of the patent; 

Or the application for the patent for the invention of the core technology has been made public by the patent administrative department under the State Council and a search report has been issued by the patent search consulting center of China National Intellectual Property Administration, showing that the core technical solution of the product has novelty and creativity.

2.    The applicant has completed the preliminary research of the product and has a basic stereotyped product, the research process is real and controlled, and the research data is complete and traceable.

3.    The main principle or mechanism of the product is the first of its kind in China, and the performance or safety of the product has been fundamentally improved compared with similar products, and the technology is at the international leading level, and has significant clinical application value.

How to register as breakthrough medical devices?

According to the Special Review Procedures for Breakthrough Medical Devices and relevant medical device regulations, Chinese and foreign breakthrough medical device registrants, under the premise of ensuring the safety and effectiveness of the product, submit the appropriate technical information and supporting documents, to apply for a special review of breakthrough medical devices, into the special review procedures for breakthrough medical devices, the review of the application for special review procedures, the review of the early intervention and have a person in charge of, in the product testing, system verification and technical review of the priority arrangements.

On October 12, 2023, China’s NMPA approved the non-small cell lung cancer tissue TMB detection kit produced by Geneseeq. As of October 12, 2023, a total of 231 breakthrough medical devices have been approved in China, including 24 IVD products.