China publishes draft of a third special fast track ‘green’ approval route

In the ever changing medical device regulatory landscape in China, Chinese regulations seem to not only grow more and more internationally aligned, but also appear to be ahead of the curve in allowing fast track product review where patient need is high.

On June 21st 2016, CFDA published a Draft for Comment version of ‘Priority Approval Process for Medical Devices’ (CFDA No. 40, 2016). This is the third special approval procedure that CFDA plans to implement besides the normal product registration route, which is largely governed by State Council No. 650 (Regulations on supervision and administration of medical devices) and CFDA Order No. 4 & No.5 (Provision on the registration of medical devices and IVD reagents, respectively).

The two special approval procedures currently enacted are for occasions of public health emergencies and to bring novel devices into the market.

Emergency Approval Process for Medical Devices (CFDA No.565, 2009) is an express approval route with the intention of prevention, control and elimination of imminent or existing public health emergencies.

Special Approval Process for Innovative Medical Devices (CFDA No.13, 2014) offers an ‘express’ approval route for devices which can be qualified as ‘innovative’ medical devices. This green track gives manufactures of innovative medical devices both ‘process priority’ benefit and ‘information communication’ advantage at varies stages of the registration process. As of June 6th 2016 there are in total 66 medical devices approved by CFDA under this special approval procedure since 2014.  Although this is an ‘express’ approval route, to be conditioned as ‘innovative’ device under stringent requirements, the complexity of obtaining an innovation patent in China can still pose an obstacle, especially for foreign manufactures, to obtain CFDA registration through this route, as at minimum the patent application needs to have been accepted before starting the fast track review process.

This recently published draft Priority Approval Process for Medical Devices (CFDA, NO.40, 2016) plans to give priority to Domestic Class III and Import Class II and Class III medical devices that fulfil one of the following conditions:

  • Diagnosis or treatment of orphan disease, and with obvious clinical advantage;
  • Diagnosis or treatment of malignant tumors, and with obvious clinical advantage;
  • Diagnosis or treatment of Elderly specific disease, and there is no effective treatment or diagnosis in China at the moment;
  • Diagnosis or treatment of Children specific disease, and there is no effective treatment or diagnosis in China at the moment;
  • Fulfills urgent clinical needs, and there are no equivalent devices approved in China. 

When this draft for comment version will be finalized and enacted is still unknown, and how ‘express’ this approval route will be in practice for product registration in China still waits to be seen. Nevertheless, it does offer an alternative registration route for manufacturers who can fill certain clinical application gaps in the Chinese market. For instance, as China’s population is rapidly aging, elderly care will become more and more a relevant topic, and so does the health care consumption (including medical devices) for elderly care.

To support the growing demand of reviews and expedited tracks, CFDA announced that they are intending to recruit additional 410 staff from the public. Among these there are 50 openings to medical device technical reviewers and an additional 10 to medical device administrative positions.

Needless to say, combined with recent CFDA regulatory development, this is yet another positive example of China moving towards a more mature, more internationally aligned, and more patient friendly regulatory system. 


Written by: Xiaoli Gou, Junior Consultant at Qserve Group and Gert Bos, Executive Director and Partner at Qserve Group

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Xiaoli Gou
Post date: July 11, 2016
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