More Class II & III Medical Devices and IVDs Exempted from Clinical Trials

The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423 IVDs. It is an effort to implement risk-based clinical evaluations, and to make medical device clinical exemptions more consistent with internationally accepted standards.

Ask us if your devices or IVDs are in the Catalog. Even if they’re not, we can develop a clinical evaluation strategy to help you avoid the expensive and time-consuming clinical trial. Send us an email at info@ChinaMedDevice.com.

For the recorded webinar on NMPA Medical Device Clinical Pathways, please click HERE

List of Exemptions from Clinical Trial

35 medical devices are added to the clinical trial exemptions list, including 16 Class III devices, after the last exemptions proposal published in July 2020:

1.      Breast tissue markers

2.      Mobile C-arm X-ray machine

3.      Tubing for continuous renal replacement therapy

4.      Venous blood reservoir

5.      Cranio-maxillofacial bone plate system

6.      Metal locking bone plate

7.      Metal locking bone screw

8.      Metal interlocking intramedullary nail

9.      Sternal ligature

10.   … …

Seven IVD reagents are exempted from clinical trial, including three Class III reagents:

1.      Mumps virus IgG antibody detection reagent

2.      Adenovirus IgG antibody detection reagent

3.      Varicella-zoster virus IgG antibody detection reagent

4.      … …

For an English copy of the Clinical Trial Exemptions Catalog, please contact us at any time. 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 IVD products. The NMPA has updated the list almost annually since it was first released in 2014, for a total of seven revisions, with more products added to the list.

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.

Source: https://chinameddevice.com/medical-devices-ivd-exempted-clinical-trial/