The NMPA CMDE (Center of Medical Device Evaluation) published the “Clinical Trial Design Types Recommendations for Non-active Implantable Devices, Neurological and Cardiovascular Surgical Devices, Dental Instruments, Radiotherapy Devices, Diagnostic Devices, and Examination and Monitoring Devices” on September 27, 2024.
These recommendations outline two potential clinical trial designs: “randomized controlled design” or “single-group design,” based on product names, structural composition, and intended use.
For clinical recommendations on predicate device comparison vs. clinical trial, please click HERE.
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For an English copy of the document with six annexes, email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.
Determine Your Clinical Pathway
Registration applicants must first determine the intended use, design features, and issues related to clinical trials that need to be addressed in the safety and performance conformity assessment. They should refer to the “Guideline for Medical Device Clinical Trial Design” and “Common Questions in Medical Device Clinical Trial Design – Single-Group Solution Target Design” to select a comparable approach. When selecting a clinical trial design type, the examples listed in this document can be used as reference.
If the product’s name, intended use, and structural composition are highly consistent with the typical products, it is recommended to conduct clinical trials according to the suggested design type. Products labeled as “randomized controlled design” in the document should follow a randomized controlled clinical trial design, while products labeled as “single-group design may be considered” may opt for a single-group target value design or a randomized controlled design.
When the product’s name, intended use, and structural composition differ significantly from typical products—such as new intended uses, designs, or novel functionalities—the examples listed in this document should no longer be used as reference. In such cases, the registration applicant should select the clinical trial design type according to the “Guiding Principles for Medical Device Clinical Trial Design.” If choosing a single-group target design, it is recommended that the applicant fully utilize communication mechanisms and discuss the matter with the Device Evaluation Center.
Devices Examples
- Continuous Hypoxia Monitoring System
- Carbon Ion Therapy Equipment
- Proton Therapy Equipment
- Plasma Coated Dental Implant System
- Coronary Drug-Coated Balloon Dilatation Catheter
- Peripheral Drug-Coated Balloon Dilatation Catheter
- Below-Knee Drug-Coated Balloon Dilatation Catheter
- Stent Graft Valve
- Decellularized Allogenic Dermis
- Artificial Breast Implant
- Bleached Artificial Dermis Repair Material
- Left Atrial Appendage Occluder
- Patent Foramen Ovale Occluder
- Left Atrial Appendage Clamp Occlusion System
- Transcatheter Tricuspid Valve System
- Transcatheter Tricuspid Clip System
- Transcatheter Pulmonary Valve Prosthesis System
- … …
For NMPA suggestion of clinical pathway for the devices above, please email us at info@ChinaMedDevice.com.