2015年医疗器械临床评价技术指导原则(英文版)

1、Annextechnical guidelines for clinical appraisal of medical devicesI drafting objectiveClinical appraisal of medical devices is the process implement by registration applicant to identify whether the product fulfill usage requirement laws and regulations basis(I)“medical devices management regulatio

2、ns”no . 650 decree of the state Council；(ii) medical devices registration management specification s no . 4 decree of the state Council；(iii)relevant specification s for clinical trial quality management of medical devices。 application scopethis guidelines is applicable To clinical appraisal of clas

3、sand class iii medical devices when they are applied for registration . it is not applicationif there is clinical appraisal technical guidelines for specific product，the corresponding clinical appraisal should follow relevent requies基本principleclinical appraisal should be comprehensive as well as ob

4、jective and corresponding data should be collected be various means such as clinical trialsclinical performance and safety data collected in clinical appraisal process should be included in analysis no matter it is positive or negatv e . CCSclinical appraisal should confirm clinical application info

5、rmation concerning application scope(such as applicable people，applicable)registration applet should draw the following conclusion through clinical appraisal : the product has the expected performance in normal usethe risk of product is acceptable compared with expected benefits；the clinical perform

6、ance and safety of product are both supported by proper evidence。clinical appraisal requirements for the product listed in catalogue of medical devices exempted from clinical trial 。for the product listed in catalogue of medical devices exempted from clinical trial ，Registration applet needs to subm

7、it documents ofthe specific clinical appraisal documents required to be submitted is as follows :(I)submit documents of comparison between relevent information of declared product and the content included in catalogue ；(ii)Submit comparison explanation for declared product and the medical devices in

8、cluded in the catalogue which have already acqqthe above-mentioned submitted documents should prove the equivalence between declared product and the product listed in the catalogue if equivalence Between declared product and the product listed in the catalogue cannot be proved，corresponding jobs sho

9、uld be carrold。requirements for analysis and appraisal with data from clinical trial and clinical use of the same variety medical devices。(I) the same variety medical devices1 definition of the same variety medical devicesthe same variety medical devices are the domestic registered products which ar

10、e identical to the declared product in the aspects of basic principleif the difference between declared product and the same variety medical devices has no adverse influence on product safety and effectiveness2.judgment of the same variety medical deviceswhen analysis and appraisal is implement with data from clinical trial and clinical use of the same variety medical devices to prove the safety and e effromthe items for comparison with the same variety medical devices should include but not limit to the items in annex 2 .the comparison content includes qu Alitative