Which Medical Devices require to Clinical Trial before SFDA approval

While applying for MD product initial registration of Class II and Class III, clinical trial information has to be submitted. The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the inspection and approval of the clinical trial of class II medical devices in their own administrative regions. The State Food and Drug Administration is responsible for the inspection and approval of clinical trial of class III medical devices.

Clinical trial shall be conducted in the medical institutions designated by the drug regulatory authorities of the government at provincial level and above. The medical institutions shall conduct the clinical trial, in accordance with SFDA Oder 5 "Provisions for Clinical Trials of Medical Devices" taken go into effect as of April 1, 2004. The qualification of medical institutions engaged in the clinical trial shall be certified by the drug regulatory authority, jointly with Ministry of Health.

Based on the different condition that whether it has been already placed into market overseas or this enterprise or applicant has already registered equivalent products in China, the detail requirements of clinical trial information are different and clarified in annex 12 of SFDA order 16 "Provision for Medical Devices Registration" taken into effect as of August 9, 2004.

If the clinical trial of medical devices conducts in China, the information provided in clinical trial report includes contracts, protocols, and the final summarized reports. Whenever necessary, SFDA may require the applicant to submit the Notice, Informed Consent and original test records.

Based on the above requirements of MD clinical trials, clinical trials of IVD reagents specifies the detail requirements in SFDA Notice [2007]229 "Management Method of In Vitro Diagnostic Reagents Registration (Interim)" taken effect as of June 1, 2007. The details contain the quality of detected product, detection unit and specifications, the qualification and quantity of clinical trial institution and the minimum quantity of specimens. Moreover the detail technical requirements of basic principle, research method, specimen volume and the establishment of clinical research report are clarified in "Technical Guideline Clinical Research for IVD Reagent" implemented on the same day.