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Med Device Registration and Regulation Reform is Deepening In China


On July 19, the 37th Meeting of Comprehensively Deepening Reform Leading Group of the Central Committee of the Communist Party of China was held, which deliberated and approved“The Opinions about Deepening the Reform of the Review and Approval System to Encourage the Innovation of Drugs and Medical Device” (Hereinafter referred to as the “Opinions”).

On August 2015, the State Council had issued the“Opinions about Reforming the Review and Approval System of Drugs and Medical Device,”, which marked the starting of the reform.

This reform has been implemented for more than a year, and a lot of medical device enterprises in the industry have tasted the “pleasant flavor”of the reform. For example, more and more innovative medical devices were approved and available in the market quickly, and more and more domestic innovative device enterprises has risen quickly.

But it is undeniable that a lot of significant problems related to the interests of medical device  enterprises and the development of medical device industry had not yet been resolved, or the problem resolving efforts, such as the overseas clinical trial data should be accepted in China, the R&D costs need to be dropped, the backlog problems of registration application were not all resolved were not enough in the previous reform.

The introduction of the new “Opinions” marked a big step forward on the success of medical device approval reform made, and measurements to speed up the availability of medical device products in the market, the reduction of enterprises’ R&D cost and competitiveness promotion of domestic products will be launched soon.

Undoubtedly, it will be good news for domestic medical device enterprises which are staying in the transition period.

In addition, compared with the documents issued by the State Council  in 2015, the name of new “Opinions” not only reflected the deepening of the existing reform, but also highlighted the connotation that  to “encourage medical device innovation”.

Relatedly, CFDA had issued 4 policy documents about encouraging drug and medical device innovation in one time, and asked for opinions from the public 2 months ago.

These 4 documents are : “Related Policies about Encouraging Drug and Medical Device Innovation, Protecting the Rights and Interests of Innovators (Exposure Draft)”,  ” Related Policies about Encouraging Drug and Medical Device Innovation, Implementing the Whole Life Cycle Management of Drug and Medical Devices (Exposure draft) “, “Related Policies about Encouraging Drug and Medical Device Innovation, Reforming the Clinical Trial  Management (Exposure draft) “, and “Related Policies about Encouraging Drug and Medical Device Innovation, Speeding up the Review and Approval of Drug and Medical Device Innovation Availability (Exposure draft).


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at

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