Device makers on a fast track in China
By: Simranjit Singh | May 18, 2016
Comprehensive clinical evidence can open the door to market access.
Navigating China’s regulatory environment can be challenging for medical device and diagnostic companies. That challenge, however, just became easier thanks to new guidelines that may allow approval of products in China without conducting additional clinical trials. This new approval path provides an opportunity for developers to strike quickly and deliver new products to market ahead of their competitors – but only if they can present clear evidence demonstrating the device can meet their strict approval criteria.
This new option came about in May 2015 when the China Food and Drug Administration (CFDA) released new technical guidelines governing medical device clinical evaluation for registration of Class II and III devices in China. The guidelines specifically cover principles for clinical evaluation of these devices, including which ones are exempted from clinical studies and which may be eligible for a clinical study waiver. The key to determining whether a device will require additional clinical studies is if the developer can demonstrate that the product is substantially equivalent to an already registered predicate product on the market in China or the rest of the world.
Currently there are five paths to registration for Class II and Class III medical devices (the highest in terms of risk of China’s three medical device classes):
For devices not included in the first path (listed in the catalogue), the fifth option is by far the fastest, most economical and feasible. It is especially useful for companies bringing new iterations of existing devices to market because they can use the first-generation product as the comparator.
This path requires developers to produce a comprehensive CER that provides clear clinical evidence establishing the safety and performance of the device.
The CER required by the CFDA is mainly based on US Food and Drug Administration (FDA) guidelines to demonstrate substantial equivalence, as well as biostatistical and meta-analysis used for CER registrations in the EU. But the resulting guidelines are unique to China, and clearly lay out what companies need to compile to avoid a full clinical trial as part of the registration process.
To meet the CER guidelines, developers need to assemble a team of experts that includes:
Ideally, medical device manufacturers should assemble the expert team early in the development process and conduct a gap analysis to determine whether the device can meet the strict criteria for a CER approval path. This is especially important if there is any question as to whether there is an appropriate comparator to demonstrate equivalence, or if the new device varies significantly from the original. In many cases, organizations might not have all three of these skill sets in-house, and have to work with a third party provider who has the depth of expertise to deliver an effective CER as efficiently as possible.
These new guidelines can deliver a significant competitive advantage for device manufacturers interested in bringing new products to market in China, but only if the companies get it right. A well-developed CER that takes all of the regulatory, biostatistical and literature review requirements into account, will increase the chance of approval by the CFDA, ensuring developers generate the most market value for their product.