Medical Device Sampling Inspection Results

On November 17, 2020, NMPA released an announcement of medical device sampling inspection results. Recently, NMPA has conducted a quality inspection on five kinds of products including Doide laser systems, ultrasonics dental descaler equipment, surgical gowns, etc. and a total of 27 batches (sets) of products do not conformity with the standards. Details for the unqualified products are:

• Doide laser system from one company does not meet the standards of emergency laser terminators;
• Ultrasonics dental descaler equipment from one company whose external marking and input power does not meet the standards;
• Surgical gowns from six companies do not meet the standards from five different aspects;
• Hemodialyzer from one company does not meet the standards relating to the clearance rate;
• Medical absorbent cotton from 11 companies do not meet the standards relating to PH, sinking time, water absorption, surface active substances.

Please email info@inspirativemed.com to get the list of products not in conformity with the standards in this NMPA audit and Brandynuoen can help you evaluate their possible impact to your products.

Link: https://www.nmpa.gov.cn/xxgk/ggtg/ylqxzhlgg/20201117171010143.html