June 21, 2017, China FDA announced the 14thnotice of medical devices quality and published quality supervision & sample inspection situation of 3 categories 247 sets products such as disposable tracheal tubes, medical electronic thermometer etc.
Random-inspected samples which does not meet the standards of medical equipment involving 3 categories 4 sets products produced by 4 medical equipment manufacturers; inspected items such as labels identification, brochures etc not meet standards are 1 category 2 sets medical equipment produced by 2 medical device manufacturers; 3 categories 241 sets medical equipment produced by 92 medical devices manufacturers meet the relevant standards for all inspected items.
At present, national Food and Drug Administration has already requested local food and drug supervision and administration departments to investigate and deal with the relevant enterprises, and asked the relevant provincial food and drug supervision and management departments to announce the disposal of the situation to the public.
In order to strengthen the quality supervision and management of medical equipment and ensure the safe and effective use of medical equipment, our national FDA recently makes quality supervision and sampling in strict accordance with frequency to an average of 2 times a month. It fully embodies the concern of government for medical equipment, it is required to stand the test of the market if you want to to go on this road farther.
Shenzhen Med-link Medical Electronics Co., Ltd. always requires all products to meet the latest national and international standards. Since it is founded in 2004, after 1 year’s planning, Med-link’s first batch of ECG cable and lead wires passed CFDA registration successfully, it is a good start and also the best proof of our efforts.
After 13 years’ innovative research in the field of medical equipment by 2017, Med-link’s independently developed temperature probe, reusable SpO2 sensor, disposable ESU pencil, pulse SpO2 extension cable, non-invasive brain electrode, IBP cable etc, all these series of products has authoritatively certified by international organizations such as CFDA, FDA, CE etc.
With long-tested experience in medical equipment market, we will not indulge in the past, and also will not simply step by step. Adapting to constantly changing medical equipment market, meeting the latest needs of different groups, Med-link Medical will constantly pursuit of high standards & high technology, and prove our strength with product quality.
Connecting life care with care, make medical staff easier, people healthier!
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