As healthcare consultants specializing in the Chinese market, we hear this question daily. This article generalizes the process to provide a hyper-simplified answer for investors and CEOs, and sales & marketing executives of MedTech companies, needing this crucial piece of information to make sound investment decisions or plan and allocate organizational resources.
It is a 2~3 year journey to register a medical device (including IVDs) with the CFDA* and for novel devices and tests, China clinical investigations likely will be required
Medical devices (including IVDs) in China are classified into Class I (lowest risk), Class II and Class III (highest risk) where Class II & Class III applications would receive rigorous technical reviews from the CMDE (Center for Medical Device Evaluation) of the CFDA.
A provincial CFDA can approve a Class I and Class II locally manufactured medical device, whereas all imported products, regardless of the classification, will be handled by the national CFDA, which generally takes a longer time, costs more, and has more stringent review processes.
It takes approximately 2-3 years to register a Class II or Class III medical device with the CFDA. The following graphic explains the various steps: the mandatory product testing, the clinical study (conditionally) purposely designed for the registration, and the technical review process. These steps combined have resulted in a time- and resource-consuming exercise in launching a medical device or diagnostic product in China.
Timeline of registering a medical device/IVD product with CFDA
Understandably the most significant investment is the clinical study purposely designed for the registration purpose, which adds a few months if not years to the timeline. Before 20141, the registration regulations were quite relaxed about the “origin” of the clinical data and registration applications were approved based on the clinical evaluation report provided by the foreign manufacturers, which were done outside China. However, that changed in October 2014 as a result of the change of CFDA’s regulation on medical device registrations that all Class II and Class III registration applications are required to conduct clinical studies in China except for those that are on the clinical study exemption list. Although the exemption list approach is somewhat analogous to FDA’s 510(k) in the sense that both regulatory authorities have referred to the existence of an already marketed product as the foundation of their decisions, CFDA has much narrower definition for the predicate devices and is much more conservative in interpreting substantial equivalence to the extent that not only the intended use of the two devices is expected to be the same, the principle of operations, the key materials or even the appearances shall be “substantially the same”. Therefore, it is wrong to assume that because the product is marketed in the US under the 510(k) process, the registration process for China would be relatively simpler and quicker than for a PMA or de novo product. As a matter of fact, it is better to use the clinical study requirement as the baseline scenario in the initial or ballpark planning process so that the project does not get stopped halfway because of insufficient funding. It is also highly recommended to conduct a pre-registration analysis to provide more clarity and details to the registration plan before one rushes into the process blindly.
Although in 2018, the CFDA published a guidance document for acceptance of clinical data generated from clinical investigations conducted outside of China, the many conditions applied from the GCP requirements to racial/genetic differences make it practically impossible to be implemented. Boston Healthcare has experience in using this pathway to submit the foreign data as supplementary evidence to the CFDA’s review process and that first-hand experience only reinforced our analysis that foreign data alone is not going to lead to the CFDA’s approval.
The same issue applies to other CFDA initiatives and pathways, such as the fast-track pathway for innovative medical devices and IVDs introduced back in 2017/2018. Under the theme of promoting innovation, the rules were rather created and implemented to serve China’s political agenda to favor and support the local medical technology players. In 2019, a Boston Healthcare analysis showed that 90% of the fast-track designations had gone to products manufactured locally by Chinese companies.
So, our advice of using 2~3 years as the baseline scenario stands as general advice although we encourage companies that have a strong local presence and strong regulatory teams to exploit those exceptional pathways to get the approval process accelerated.
As this article is being written, China has started a new round of policy changes to the medical device and IVD regulations, unveiled by the revision of the Regulation on Supervision and Administration of Medical Devices that was published in March 2021, which will come into effect from 1 June 2021.
Boston Healthcare will closely monitor these ongoing policy changes and analyze the impact of the changes to help clients stay on top of industry trends and develop strategies and action plans to tap into the opportunities or tackle the issues. Please contact us to learn how we can help.