GCP and Clinical Research Standards in the European Union * Labeling samples * Compliance statement 37 Q. What is the NMPA's requirements for clinical evaluation of medical devices in China? A. On May 21, 2015, NMPA released a Guidance of Clinical Evaluation for Medical Device, which clearly defined the regulatory requirements for clinical evaluations of any type II or III medical devices. According to this guidance, the followings would be required to be submitted by an applicant who has a plan to conduct clinical evaluation of medical devices: Type Requirements R1 R2 Comments Needs the following documents to demonstrate the equivalence of devices to be registered to the products listed in the "Catalogue": 1. Comparison data reports of the devices to be registered with the product data listed in the "Catalogue" Medical Devices Listed in "Catalogue of Clinical Trial Exemption" 2. Comparison illustration of the devices to be registered with the products that are marketed in China and listed in the "Catalogue" Conclusion: In the normal uses, the devices to be registered show a expected performance; compared to the expected benefits, the risk of the devices to be registered is acceptable; both clinical functions and safety of the devices to be registered are able to be supported based on the appropriate evidences. No difference √ √ Evaluations and comparisons based on the data collected from clinical trials or clinical applications of similar type of products Needs following documents to demonstrate the equivalence of the devised to be registered with the similar types of one or more products that are registered in China: 1. Comparison item list of the devices to be registered with the similar type of products; 2. Analyze the evaluation methods; 3. Requirements of references and screening; 4. Program of references and screening process; 5. References and screening reports; 6. Clinical evaluation report Conclusion: in normal uses, the devices to be registered may meet defined performance; compared to the expected benefits, the risk of the devices is acceptable; both clinical functions and safety of the devices to be registered are able to be supported based on the appropriate evidences √ √ Conduct a clinical trial in China 1. Conduct a clinical trial at a certified clinical institution; 2.Conduct a clinical trial in a compliance with GCP standards of medical devices; 3.Submit clinical protocol and clinical study report at the registration process. √ √ Devices not listed in Catalogue of Clinical Trial Exemption 647