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》
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.
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.
- 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.
For more information, please feel free to contact us.