I. Analysis on overall situation
Up to June 10, 2015, CFDA issued 17 batchesof medical device approval issuance notice during the first half of this year:2207 varieties in the imported medical device approval; 1067 varieties in thedomestically-made medical device approval; 2307 varieties in amendment approvaland 286 varieties in correction approval. 23 batches of imported medicaldevices were issued; 1260 varieties in imported device approval were issued.
II. Approval of imported medical device
In the 2207 imported medical deviceapprovals, 1126 varieties first obtained the registration approval, 952 ofwhich were ordinary devices that obtained first registration, and 113 of whichwere diagnostic reagents that obtained first registration; 1081 varietiesobtained the continued (certificate replacement) registration approval, 782varieties were ordinary devices that obtained continued registration and 236varieties were the diagnostic reagents that obtained the continuedregistration.
The data indicated that, the ratio betweenthe imported medical devices that obtained the first registration and thosethat obtained the continued registration was basically 1:1; the proportion ofdiagnostic reagent was slightly low, about 15%.
III. Approval of domestically-made medical device
In the 1067 domestically-made medical deviceapprovals, 385 varieties first obtained the registration approval, 146 of whichwere ordinary devices that obtained first registration, and 239 of which werediagnostic reagents that obtained first registration; 682 varieties obtainedthe continued (certificate replacement) registration approval, 484 varietieswere ordinary devices that obtained continued registration and 198 varietieswere the diagnostic reagents that obtained the continued registration.
The data indicated that, the proportion ofthe domestically-made medical devices that obtained the first registration andthose that obtained the continued registration was about 35% and 65%,respectively; the proportion of diagnostic reagent was slightly low, about 40%.
VI. Summary
The data indicate that, up to the first halfof 2015, the imported medical device still plays the dominant position; underthe system of new registration regulations, the number of amendment approvalswill significantly increase. The variety and number of domestically-mademedical devices still remain low, the innovation abilities of domesticmanufacturing enterprises are insufficient, and the domestic enterprises stillfocus the efforts on the development of in vitro diagnostic reagents.
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