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NMPA Announced 25 Batches of Medical Device Products That Did Not Comply with the Standard Regulations
2019-05-14 14:13

Notice regarding the Inspection Result from The Center for Medical Device Evaluation (CMDE)

In an effort to strengthen the management of quality control and to ensure the safety and effective use of medical device products, the National Medical Product Administration (NMPA, formerly CFDA) performed quality assessment sampling against 7 product categories, namely γ-glutamyl transferase assay reagents (kits), medical X-ray protective tools (protective clothing, skirts, scarfs), human blood and blood collection plastic containers (blood bags) and etc., with 151 batches in total.

Among the examined groups, 25 batches of medical device products failed to meet the standard regulations and specific standards for labeling and usage manual in which 19 batches of 6 product categories from 17 companies and 7 batches of 2 categories from 7 companies are involved, respectively.  It is concluded that the medical device products including the 126 batches of 5 categories involving 85 companies are considered to abide the standard requirements.

 

Original article:

https://mp.weixin.qq.com/s/LjsffHyiRx6bJtNxvM4A9w


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