Clinical Affairs

/Clinical Affairs
Clinical Affairs 2017-07-04T12:39:14+00:00

CFDA Regulations on Clinical Evidence

According to the new CFDA Regulation on Medical Devices, Filing of Class I medical devices requires no clinical trials. Clinical trials are required for registration of Class II and Class III medical devices.

Clinical trials are not necessary in any of the following circumstances:

(1) A predicate medical device with explicit operation mechanism, well established design, and mature production process has been marketed and used for years without any serious adverse event and without any change of normal purpose;

(2) Safety and effectiveness of the device can be proven through non-clinical evaluation;

(3) Safety and effectiveness of the device can be proven through analysis and assessment made with data from clinical trials or clinical use of predicate medical devices.

The catalogue of medical devices exempted from clinical trials should be prepared, adjusted, and published by CFDA. For products not included in this catalogue, if the safety and effectiveness of the medical devices can be proven through analysis and assessment made with data from clinical trials or clinical use of predicate medical devices, the applicant can describe the case during registration application and submit relevant supporting documents.

Clinical Trials Application

Any clinical human tests with high risk to be performed for Class III medical devices should be approved by CFDA. The catalogue of Class III medical devices requiring clinical trial review shall be prepared, adjusted, and published by CFDA.

Clinical trials for medical devices should be performed by a qualified clinical trial organization according to the requirements defined in medical device clinical trial quality management regulations. Production of clinical trial samples should meet relevant requirements defined in the medical device quality management system.

Procedures for Clinical Trials

Clinical trials for medical devices should be performed by a qualified clinical trial organization according to the requirements defined in medical device clinical trial quality management regulations. Production of clinical trial samples should meet relevant requirements defined in the medical device quality management system.