On September 18, 2021, the NMPA (National Medical Products Administration) published the clinical trial exemption list for medical devices (No.71-2021) and IVD reagents (No.70-2021) in accordance with Order 47 and Order 48 respectively, which became effective on October 1, 2021.
Highlights
Both clinical trial exemption lists now cover 1,010 medical devices and 423 IVDs as below:
| Medical Devices | IVD Reagents | |
| Class II | 809 | 374 |
| Class III | 199 | 49 |
| Class II/III | 2 | – |
| Total | 1010 | 423 |
A total of 423 products were exempted from clinical trials in this catalog including two product categories of Class III in vitro testing reagents and 11 product categories of Class II in vitro testing reagents. Comparing to the previous catalog released in December 2019, 7 newly added products include Class III products such as mumps virus IgG antibody test reagents and varicella-zoster virus IgG antibody test reagents, and Class II products such as lead test reagents.
The clinical trial exemption list for IVD reagents do not cover self-testing or new-born testing related products. The following class II IVD reagents are exempted from clinical trials:
- Flow cytometric analysis reagents (tubes or microspheres)
- Custom reagents (e.g. fluorescence compensation beads)
According to Order 739, clinical trials can be exempted if the safety and effectiveness of medical devices can be proven by other non-clinical evaluation studies such as existing clinical data of predicate devices in the market, clinical evaluation, etc. In August 2021, Order 47 and 48 further specified that applicants should ensure the intended use of predicate devices remains unchanged whilst no serious adverse events have occurred in the past, in order to use the existing clinical data to apply for NMPA approval.
Following the announcements on the clinical trial exemption list for medical devices and IVDs, the CMDE (Center for Medical Device Evaluation) of the NMPA released the following three technical guidelines:
- Clinical evaluation of IVD reagents from the clinical trial exemption list
- Clinical trial for IVD reagents
- Determining whether to conduct clinical trials on medical devices
For the clinical evaluation of IVD reagents, the applicants can carry out the following studies:
- Comparison study with predicate devices
- Comparison study with measurement procedures / diagnostics accuracy standards
- Comparison study with product information related changes
Clinical evaluation report requirements:
- Descriptive comparative analysis
- Comparative performance data
Cisema can customize a clinical pathway strategy for foreign manufacturers seeking the most appropriate route to NMPA approval in China covering CRO (clinical research organization) services and CER (clinical evaluation report) composition.
By Chelsey Shao and Jacky Li. Contact Cisema if you would like to learn more.
