Based on the《Regulations for the Supervision and Administration of Medical Devices》and《Technical Guiding Principle on Medical Devices Clinical Evaluation》,the medical devices of Class II/III must be conducted clinical trials unless they meet the one of the following circumstance.
1. Belonging to《Catalogue of Medical Devices Exempted from Clinical trials in China》
The catalogue is issued and adjusted by CFDA. If you want to obtain the latest Catalogue, please click here.
If your product belongs to the catalogue, you can submit the following data to apply for exempting from clinical trials to CFDA.
If your product belongs to the catalogue, you can submit the following data to apply for exempting from clinical trials to CFDA.
- Submitting the comparison data obtained by comparing relative information of your product and the detailed content in the catalogue.
- Submitting the comparing explains obtained by comparing your product and the registered medical devices in the catalogue. The comparing explains shall include《The table of comparison between application and registered medical devices》(Download), and corresponding supporting data.
If these data can prove your product is equivalent to the registered medical devices in the catalogue, it can exempt from clinical trials. Otherwise, the relevant assessment shall be carried out in according with other requirements of this principle.
2. The safety and effectiveness of medical device can be ensured by analysis and evaluation the data achieved in the clinical trials or clinical use of the same type medical device.
If your product is equivalent to the registered medical devices on the aspect such as basic principle, structure composition, materials, production process, performance requirements, safety evaluation, national or industrial standard, intend use, etc. You can use the relevant of the same type medical device to apply for exempting from clinical trial.
- Determination of the same variety of medical devices
- Evaluation pathway (Click here)
- The collection of relevant data of clinical trials and clinical usage of the same variety of medical devices.
- Conducting the clinical evaluation for your product according to the clinical data of the same variety of the medical devices.
- Clinical evaluation report.
- The safety and effectiveness of medical device can be ensured via other data rather than clinical trials.
In conclusion, you should judge your product whether can exempt from clinical devices before registration, because it will help you reduce a lot of cost of clinical trial.
For more information, please feel free to contact us.
For more information, please feel free to contact us.
