Shandong Province medical equipment special rectification 13 companies were ordered to stop production

Pharmaceutical Network December 5 News 5, the reporter from the provincial government Information Office held in Shandong Province special rectification of medical equipment in 2017 and three years of special rectification action news conference was informed that three years, the province's food and drug regulatory system in the special rectification The Chinese communists inspected 843 manufacturing-related medical equipment manufacturers and 36,631 enterprises and 38,846 units were used to give warnings, ordered rectification of 8571 times, ordered 1,039 stops and 10,900 penalties, of which a total of 36,994,000 yuan was punished this year There are 152 medical device manufacturers, 13550 enterprises and 8675 units in use, of which 610 were given warnings and 2,160 corrections were ordered, 13 were ordered to suspend production and 13,800 were fined for confiscation.

Since 2015, our province has been in continuous operation for three years medical instruments In the field of regulation, special operations were conducted to focus on seven major categories of products such as contact lenses, condoms, in vitro diagnostic reagents, customized dentures, disposable sterile medical devices, sodium hyaluronate for injection, chitosan products, and experiential formulas Conduct special rectification operations, crack down on undocumented production and operation, the production of counterfeit brands and the sale of undocumented products, tampering with labeling instructions and other illegal activities.

For the first time in 2017, a sampling of early-warning sampling, household-type sampling, special sampling and emergency sampling were set up in the sampling plan of our province in 2017, which enhanced the scientificity and targeting of sampling sampling. In 2015, a total of 635 batches of 48 varieties Products, the sampling failure rate was 4.7% .Total sampling of 114 varieties of 675 batches of products in 2016, the sampling failure rate was 5.2% .In 2017 for a more concentrated social reflection of sodium hyaluronate for injection, condoms, customized dentures , Contact lenses 4 products to carry out special rectification work, a total of 151 random sampling, sampling failed rate of 4.1% .From the number of cases filed and investigate the situation, the number of cases of illegal and declining, steady and orderly medical device market order. Rate stabilized at about 95% product quality Stable and reliable.