Management Administration issued in 2013 the first one National Medical Device Quality Announcement

Management Administration issued in 2013 the first one National Medical Device Quality Announcement



     Recently, the State Food and Drug Administration of the first one released in 2013 (total of 1) Notice the quality of national medical equipment, released a balloon dilatation catheter, metal plates, endoscopy (Ⅰ) (fiber endoscopes and in addition to hysteroscopy, laparoscopy other than rigid optical endoscope), low-frequency therapeutic equipment and optical treatment equipment for quality supervision and testing results.

    

     The total testing balloon dilatation catheter 11 batches of products, on examination, testing projects for all products meet the standard requirements. Testing 35 batches of metal plates, on examination, 31 batches of product testing projects meet the standard requirements, four batches of products some testing project does not meet the standard requirements. Endoscopic testing 23 batches, on examination, testing 21 batches of projects meet the standard requirements, two batches of product testing project does not meet some standard requirements. Low frequency therapeutic equipment testing 13 batches, on examination, seven batches sampled projects meet the standard requirements, six batches of products some testing project does not meet the standard requirements. Testing optical therapy equipment 38 batches, on examination, 16 batches of product testing projects meet the standard requirements, testing 22 batches of products some items do not meet the standard requirements.

    

     At present, the province (city) food and drug supervision and management departments are in accordance with the General Administration of the request, according to "Medical Devices Regulations" provisions of the results of this testing does not meet the standard requirements of the product and the relevant agencies for investigation.