NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)” on July 31, 2024, which newly-includes 23 medical devices. Feedback needs to be submitted by August 30, 2024. Implementing risk-based clinical evaluation, the catalog is intended to make clinical exemptions more consistent with internationally accepted standards.
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 need 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 Draft Catalog
- Neuro-monitoring endotracheal tube
- Radioactive seed implantation puncture needle
- High-pressure balloon dilation catheter with infusion port
- Atrial septal puncture sheath
- Drill for bone marrow infusion access
Class II Devices in the Draft Catalog
- Personalized 3D printed surgical model
- Radiotherapy ancillary equipment
- Spinal endoscope
- Dynamic blood pressure recorder
- Telemetry monitoring system
- Remote monitoring system
- Body composition analyzer
- High-flow respiratory humidification therapy device
- Defibrillation electrodes
- Nebulizer mask
- Pneumatic ballistic extracorporeal shock wave therapy device
- Oral digital impression scanner
- Temporary crown and bridge
- Customized orthodontic appliance
- Radioimmunoassay gamma counter
- Reproductive tract secretion analysis instrument
- Flow cytometry instrument
Devices Description Changes
Product names and descriptions for some devices are proposed to be amended:
- Balloon dilation catheter
- Intravascular retrieval device
- Distal protection device
- 3D printed osteotomy guide
- Electronic laparoscope
- Electronic upper gastrointestinal endoscope
- Electronic nasopharyngoscope
- Electronic lower gastrointestinal endoscope
- Electronic cystoscope and pyeloscope
- Non-invasive automatic blood pressure monitor
- Multi-parameter monitor
- Breathing circuit
- Breathing circuit for anesthesia machines and ventilators
- Cooling blanket
- Head pins
- Liquid and paste dressings
- Contact lens saline solution
- Contact lens care products
- Orthodontic retainer
- Disposable vacuum blood collection container
For an English copy of the Clinical Evaluation Exempt Draft Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For our service page on clinical evaluation exempt, please click HERE