NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally accepted standard, NMPA stated in the notice.
Ask us if your devices or IVDs are in the Catalog. Even if not, we can develop clinical evaluation strategy to help you avoid the expensive and time-consuming clinical trial. info@ChinaMedDevice.com.
35 medical devices are added to the clinical trial exemptions list, including 16 Class III devices:
Seven IVD reagents are exempted from clinical trial, including three Class III reagents:
A total of 1,090 medical devices and 423 IVDs has been exempted from clinical trials in China since the first exemptions catalog issued in 2014.
For an English copy of the draft Clinical Trial Exemptions Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
Clinical trials should be conducted when applying for class II and III medical device registration, unless they are on the clinical trial exempt List. The following principles are required for a device to be on the List：
The List includes both medical devices and in vitro diagnostic (IVD) products. NMPA has updated the List almost annually since it was first released in 2014, for a total of six revisions, with more products added to the list with each revision.
No clinical trials are required if class II and III devices are on the List. An exemption CER is sufficient for registration application, even though it is a high-risk class III product in the NMPA classification List. Therefore, it is important to check the latest version of the List. Also, it is crucial to correctly interpret whether the device matches others on the List. An incorrect interpretation could be costly and time consuming to correct in the registration process.