The CMDE has proposed an update to the China Clinical Trial Exemption List. Industry stakeholders are invited to feedback on the proposals by August 30, 2024 – see below for details on how to do so. The update includes 23 newly added products and 20 modifications to existing products already on the list.
There are specific clinical evaluation exemption lists, which the NMPA publishes and updates occasionally. If a product appears on the list, it is clear that there is no need to undergo a clinical trial in China for NMPA registration and a Clinical Evaluation Report will be sufficient. The latest batch of exempted products was released in July 2023. Currently, on the China clinical trial exemption list, there are:
Products proposed for inclusion in the clinical trial exemption list
| Classification Category | Classification Code | Product name |
|---|---|---|
| II | 02-12-00 | Personalized 3D printed surgical models |
| III | 03-13-06 | High-pressure balloon dilation catheter with infusion port |
| III | 03-13-28 | Atrial septal puncture sheath |
| III | 04-12-00 | Bone marrow infusion needle and drill |
| II | 05-04 | Radiation therapy equipment |
| III | 05-04-00 | Radioactive seeds are implanted using a puncture needle |
| II | 06-14-01 | Spinal endoscopy |
| II | 07-03-03 | Ambulatory blood pressure recorder |
| III | 07-04-00 | Neurally monitored endotracheal intubation |
| II | 07-08-01 | Telemetry monitoring system |
| II | 07-08-02 | Remote monitoring system |
| II | 07-09-07 | Body composition analyzer |
| II | 08-01 | High-flow respiratory humidification therapy device |
| II | 08-05-12 | Defibrillation electrodes |
| II | 08-06-12 | Fogging mask |
| II | 09-04-02 | Pre-habilitation trainer |
| II | 09-04-05 | Pneumatic ballistic extracorporeal pressure wave therapy device |
| II | 17-01-05 | Oral digital impression machine |
| II | 17-06-03 | Temporary crowns, bridges |
| II | 17-07-07 | Custom-made appliances |
| II | 22-08-01 | Radioimmunoassay γ counter |
| II | 22-09-06 | Instruments for the analysis of genital secretions |
| II | 22-10-01 | Flow cytometry lattice instruments |
Modifications to products already listed in the clinical trial exemption list
The proposed changes to products already listed in the medical device clinical trial exemption list concern various types of changes including changes to the classification code, the product name, and the product description. They do not include changes to the classification category.
Change of classification code:
- Head nails (change of code from 13-06-03 to 03-14-02). The product is made of stainless steel and should be used in conjunction with a skull fixator to fix the patient’s head and neck in a specific position during surgical procedures requiring severe repair of the skull. The product is non-implantable, is only used intraoperatively, has short-term contact with the human body, and is removed immediately after surgery.
Change of product name:
- Non-invasive automatic blood pressure measurement to Electronic sphygmomanometer
- Multi-parameter monitor to Patient monitors
- Cooling blankets to Physical cooling equipment
Change of product description:
- There are 17 proposed changes to product descriptions. In most instances, the changes are very slight – please contact your NMPA Legal Agent to understand how these may affect your product certificates.
How to submit comments:
Send your comments using the feedback form which can be found in Annex 2 of the original announcement and send it to the email address huangyl@cmde.org.cn before August 30, 2024. Please indicate “2024 Device Exemption Catalogue Feedback” in the subject line.
Further information:
- To read the original announcement click here.
- For assistance on product classification or clinical trial exemption, please contact Cisema.
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