NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices” on May 13, 2025, which newly-includes 27 medical devices, including 7 Class III and 20 Class II devices. Implementing risk-based clinical evaluation, the catalog is intended to make clinical exemptions more consistent with internationally accepted standards.
In total, 1047 medical devices have been exempted from clinical evaluation.
Ask us if your devices 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.
How the Exempt Catalog Works
A major change between decree 739 and decree 680 is that the “Clinical Trial Exempt Catalog” is replaced by “Clinical Evaluation Exempt Catalog”. Previously, for class II and class III medical devices on the clinical trial exempt catalog, the clinical trial is not required, the applicant only needs to submit a basic CER (Clinical Evaluation Report). Now, the first thing to do when deciding the clinical pathway for China registration is to check the “Clinical Evaluation Exempt Catalog”. If the device is included in the “Clinical Evaluation Exempt Catalog”, the clinical trial is not required either. Instead of a basic CER, the applicant needs to submit the comparison document for the product to be registered:
1) the corresponding content in the catalog.
2) the predicate already approved in China.
The items to be compared include but not limited to the working principle, components, material, performance requirements, sterile/disinfection method, application scope, methods about how to use the device. Based on the comparison, if any difference between the predicate and the product to be registered, the applicant needs to justify that the difference will not lead to new risk(s) in terms of product safety and effectiveness.
The submitted comparison document needs to be able to prove that the product to be registered is essentially the same as the product in the “Clinical Evaluation Exempt Catalog”, otherwise, the applicant needs to identify and collect the clinical evidence and submit the CER together with the clinical evidence the CER is based on.
The following principles are required for a device to be on the exempt catalog：
• 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.
Class III Devices in the Catalog
The following Class III devices are exempted from clinical trial:
- Intracranial Balloon Dilatation Delivery Catheter
- Atrial Septal Puncture Sheath
- Dialysis Indwelling Needle
- Disposable Sterile Injection Needle
- Disposable Sterile Side-Hole Blunt Needle
- Disposable Endoscopic Injection Needle
- Preformed Polymer-Based Crown and Bridge Material
Class II Devices in the Catalog
- Personalized 3D Printed Surgical Models
- Ear Endoscope
- Spinal Endoscope
- Non-Invasive Ambulatory Blood Pressure Monitor
- Electromyography (EMG) Evoked Potential System
- Telemetric Monitoring System
- Remote Monitoring System
- High-Flow Respiratory Humidification Therapy Device
- Liposuction Cannula/Needle
- Eustachian Tube Balloon Catheter
- Intraoral Digital Scanner
- Temporary Crown and Bridge
- Disposable Acupuncture Needle
- Blood Cell Morphology Analyzer
- Integrated Immunoassay System
- Indirect Immunofluorescence Analyzer
- Biochemical Immunoassay Analyzer
- Urine Analysis System
- Other Body Fluid Analysis Instruments
- Other Body Fluid Morphology Analysis Instruments
Also, there are 25 medical devices whose product description are changed.
For an English copy of the Clinical Evaluation Exempt Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For our service page on clinical evaluation exempt, please click HERE