In the effort to strengthen the review quality of medical device and improve the safety and effective use of medical device products, China NMPA carried out the sampling inspection on 877 batches range from 15 product categories: alanine aminotransferase assay kit, abdominal puncture instrument, numerical control pneumatic tourniquet device and etc. The review results indicated that 59 batches do not comply with the standard guidelines.
1. 50 batches from 12 product categories involving 44 enterprises do not meet the standards of medical device products
2. 9 batches from 3 product categories involving 8 enterprises do not meet with the standards of labels and product description for medical device products
It is concluded that 818 batches from 13 product categories involving 366 enterprises fully comply with the standards of medical device products.
Published on Jun 5, 2019