Clinical evaluation is to use public information or clinical usage information to determine the safety and effectiveness of a product. CFDA allows clinical evaluation if a product meets one of the following conditions:
- A product is a Class I device.
- A product is exempt from Clinical trial requirements per CFDA published exemption lists.
- A product has another product that is the same and the information of the device is legally obtained and can meet strict equivalency criteria.
The Clinical evaluation report must include literature research protocol and summary, post market surveillance report, adverse events or reportable events information, and other information that demonstrate the product’s safety and effectiveness.
Whitney consulting has successfully many products using clinical evaluation route.
We offer services in:
- Drafting clinical evaluation reports based on CFDA requirements.
- Literature research (protocol, research and summary).
- Post-market research.
- Translation of scientific articles.