Medical network - June 12 medical instrument flight check highly concerned problem, has been in the industry since 2017, the national various provinces and cities have started a medical device manufacturing enterprise in the region flight inspection work. Zhejiang province food and drug administration has begun flight check, not only led to the production of a batch of production enterprises improvement or rectification within a time limit, part of the enterprise product in zhejiang province of medical consumables has been hanging network at the provincial level qualification has been suspended. 

 

Drug safety for YiXie GMP implementation of fly directly contacted with the inspection results and development planning commission of centralized purchasing, a fly, two departments impose penalties at the same time, in this way, who will dare to violate YiXie GMP rules? 

 

In zhejiang, 15 disarmed enterprises have been discontinued: 6 shutdowns, 9 rectification 

 

On June 9, the zhejiang provincial pharmaceutical administration issued a notice on the status of medical devices in the production of medical devices in 2017 (the first batch). 

 

Recently, the zhejiang province food and drug administration organization 15 medical device manufacturing enterprise for the flight check, the results are 15 enterprise quality management system has defects, does not conform to the stipulations of the YiXie GMP requirements. Of those, six have been ordered to halt production and rectification, and nine others have been ordered to do so. 

 

The flight details are as follows: 

 

In the announcement, zhejiang province food and drug administration requirements at the same time, the related city bureau for the companies involved in violation of the regulations on the supervision and administration of medical devices and related laws and regulations shall be filed for investigation, could lead to potential safety hazard products recall in a timely manner. 

 

The flight test failed, and eight enterprises were suspended 

 

On the same day (June 9), zhejiang provincial drug procurement center issued "a public announcement on the suspension of the online trading qualification of some medical device manufacturers". 

 

Of the public said, according to the zhejiang province food and drug administration issued on June 9, "about 2017 flight check the situation of medical device manufacturing enterprise notice (the first), and zhejiang province YaoXie centralized purchasing relevant documents, intends to suspend 8 companies in zhejiang province medical consumables procurement system of online transactions. The relevant public notice period is June 10, 2017, solstice, June 16, 2017. 

 

Eight companies include: 

 

 

 

Two of the companies listed in the list were ordered to halt production and rectification in the warning notices issued by the drug administration in zhejiang province, and six were ordered to rectify the situation within a specified period of time. 

 

Because of the food and drug administration organization flight failed the examination, led directly to the products of related companies in health development planning commission have suspended netting, zhejiang this joint punishment is rare in the country, will also fly to check the power of further escalation. 

 

If all the provinces and cities of the country are so, who dare not strictly observe the rules of GMP?