Our province strengthens the supervision of sterile and implantable medical devices
The reporter learned from the Provincial Food and Drug Administration that at present, the provincial regulatory agencies at all levels have inspected 132 sterile and implantable medical device manufacturers, 4,325 operating companies, and 8,328 user units, and ordered the correction of 45 manufacturers and operating companies. There were 753 enterprises, 1284 user units, 32 operating enterprises and 108 user units were filed for investigation and prosecution, and initial results were achieved.
According to the relevant person in charge of the Provincial Food and Drug Administration, our province will further strengthen the supervision of sterile and implantable medical devices, strengthen the awareness of risk prevention and control, and reduce the lack of awareness of management personnel of regulations, adverse events and complaints and reports, and unqualified supervision and sampling Enterprises in 10 other situations are listed as key objects of supervision and inspection, and the production and operation enterprises and users are urged to fulfill their main responsibilities and to properly resolve potential risks.
It is understood that the Provincial Food and Drug Administration arranged a total of 1265 batches of 69 varieties throughout the year, including 422 batches of 6 sterile products including disposable infusion sets, and 51 batches of 4 implantable products including drug-coated stent systems. Sterile and implantable medical devices sampling inspection batches accounted for 37% of the total batches.