The 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 evaluations, and to make medical device clinical exemptions more consistent with internationally accepted standards, the 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.
Contact us at info@ChinaMedDevice.com.
List of Exemptions from NMPA Clinical Trial
35 medical devices are added to the clinical trial exemptions list, including 16 Class III devices:
- Breast tissue markers
- Mobile C-arm X-ray machine
- Tubing for continuous renal replacement therapy
- Venous blood reservoir
- Cranio-maxillofacial bone plate system
- Metal locking bone plate
- Metal locking bone screw
- Metal interlocking intramedullary nail
- Sternal ligature
- … …
Seven IVD reagents are exempted from clinical trial, including three Class III reagents:
- Mumps virus IgG antibody detection reagent
- Adenovirus IgG antibody detection reagent
- Varicella-zoster virus IgG antibody detection reagent
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.
What is the Clinical Trial Exemption?
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 working mechanism is clear.
- The design and production process are mature.
- Similar types of medical devices have been marketed and used in clinical settings for many years.
- There is no record of serious adverse events.
- The medical device is safe and effective through evidence of nonclinical evaluation.
- The analysis and evaluation of data obtained from clinical trials, or clinical use of the similar types of medical devices, can demonstrate safety and efficacy.
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.
