By Stewart Eisenhart, Emergo Group
The China Food and Drug Administration (CFDA) recently announced significant changesto its regulatory system for medical devices. Revised regulations will go into effect on June 1, 2014, affecting areas including new clinical trial requirements, Class I device reviews and registration validity timeframes.
Based on a careful Emergo Group analysis of the CFDA’s revisions, we’ve identified several key areas that will impact medical device registrations in China.
CFDA medical device classification
The CFDA has revised its definition of medical devices, and will maintain its three-tier device classification system (Class I, II and III). The CFDA currently maintains an official device classification catalogue that is available online (Chinese only). In case of a new medical device that is not included in the classification catalogue, manufacturers may either submit a Class III device application or go through an official process for requesting the classification.
In order to request a classification from the CFDA, a device manufacturer previously had to apply for classification determination as well as attend a meeting with the regulator; this process could take from six to more than 12 months. Now, manufacturers unsure of how to classify their devices can submit these applications online and then send hard copies of their product information to the CFDA. CFDA staffers then hold an internal meeting and issue their classification decisions within 20 working days.
Registration and notification process changes
Devices categorized as Class I will undergo a notification review process, while Class II and III devices will undergo a registration process. Under the current Chinese review system, all manufacturers must submit similar application documentation regardless of their product classifications in order to receive Import Medical Device Registration Certificates (IMDRC). Now through the new notification market pathway, it is expected that manufacturers of lower-risk Class I devices will face less onerous application requirements, but detailed CFDA guidance on the notification process has yet to be made available.
Validity of Medical Device Registration Certificates
The CFDA will extend the validity timeframes of Medical Device Registration Certificates from four years to five years. After five years, registrations will need to be renewed. An Application for renewing registration should be submitted to the CFDA no later than six months before the certificate expires, or else the renewal application will not be accepted. According to the new regulation, as long as renewal applications are submitted on time, registrants will be permitted to continue importing products after their registrations expire, even if still waiting for CFDA approval.
Medical device clinical trial requirements in China under the current regulatory system can prove highly challenging for foreign manufacturers of some Class III devices; for these products, the CFDA only accepts data procured from clinical trials conducted in China. Now Chinese regulators are extending clinical trial requirements to all Class II and Class III devices, while establishing certain criteria for the CFDA to list exceptions:
- First, in an approach reminiscent of the US FDA’s Substantial Equivalence standard, the CFDA may waive clinical trial requirements for devices based on mature and well-established manufacturing processes, designs and methods of use, and that function similarly to registered devices that are already marketed in China.
- Second, devices whose safety and effectiveness can be proven through non-clinical assessment may be exempt from CFDA clinical trial requirements.
- Third, clinical trial requirements would be waived in cases where a device’s safety and effectiveness can be proven by evaluating clinical data for similar products already sold in China.
The CFDA plans to publish a catalogue of medical devices exempt from clinical trial requirements. Currently in draft form, the official catalogue is expected to be published in the near future.
There will also be a list of high-risk Class III devices that will require manufacturers and sponsors to obtain CFDA approval before conducting clinical trials.
Conclusions: Ongoing challenges
How the CFDA’s regulatory revisions will impact the Chinese medical device registration process remains unclear. Class I manufacturers may find it easier to obtain market access from the CFDA, but further details on the approval process cannot be verified until guidance on the new Class I notification process is published. Extending clinical trial requirements for Class II and III devices, on the other hand, will make the approval process for manufacturers of higher risk devices more challenging in terms of time and cost.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.