24 foreign giant companies have been inspected | are defective, two were stopped imports

Pharmaceutical Network March 1 hearing On February 27, 2018, the website of China's State Administration of Drug Control of the People's Republic of China released the inspection results of the overseas production sites of 8 medical equipment enterprises, which is also the result of the third batch of overseas inspections of 2017 announced by General Administration of Drug Control.

SFDA started in 2015 overseas medical instruments produce enterprise Production site inspection work, then chose Johnson & Johnson and Medtronic two global medical device industry ranked the top two companies as the inspection object.

In 2016, the General Administration of Drug Control has conducted on-site inspections on 33 varieties of 19 enterprises in 8 countries.

In 2017, SAIC conducted on-site inspection of 46 products in 24 enterprises in 10 countries, of which 6 were still in trial production.

In 2018, the number of inspection enterprises planned by the General Administration of Drug Administration will have to increase to more than 30.

Drug Administration of the inspection of overseas machinery enterprises more and more.And in 2017 the inspection results, the first time the General Administration of Drug Administration announced to the Internet, is expected to 2018 inspection results will be made public.

The import products of 24 enterprises examined by the State Administration of Direct Supervisions Administration of China in 2017 involve orthopedic supplies, X-ray machines, IVD reagents, vascular catheters, stents, dressings, electrode needles, hemodilution devices, defibrillators, pacemakers, staplers, etc. .

These 24 were checked enterprises, no one 'zero defect' clearance.

Two of these companies were also suspended in import of related products because of irregularities: calcium sulfate and resorbable artificial bone meal from Biocomposites Ltd., HER-2 from Leica Biosystems Newcastle Ltd, 2 test kit (immunohistochemistry).