The Linfen Market Supervision and Administration Bureau conducts a special inspection of a one -time sampling swab (device)

According to the current epidemic situation, in order to further strengthen the supervision of medical device, strictly control the quality and safety risks of the first type of medical device in nucleic acid testing, and fully ensure the quality and safety of medical device prevention and control of the epidemic. Based on the duties of the Linfen Market Supervision and Administration Bureau, the Linfen Market Supervision and Administration Bureau issued the "2022 Medical Device Supervision Safety Tips" to the county (city, district) municipal supervision bureaus (branch), and arranged to deploy a one -time sampling swab (device) operation. Special inspection work in use. Recently, the organizational law enforcement officer went to Yicheng County to conduct special inspections on a one -time sampling swab (device) production enterprise.

In -depth production workshops to view key production processes and product -related technical materials, and focus on inspection from personnel hygiene, factory facilities, production equipment, raw materials procurement, production management, quality control, sales and after -sales service, unqualified product control, etc. Risk management and control, urge enterprises to implement the main responsibility and quality management system. I continuously find the problems and defects in the operation of the quality management system, and put forward rectification requirements for the problems found in the inspection, guide enterprises to organize production in accordance with the relevant legal specifications of medical device, product standards and technical requirements, and urge enterprises to do a good job of closed -loop management of risks. Establish the production specifications and quality and safety of epidemic prevention. At the same time, enterprises are required to carry out comprehensive self -inspection and self -correction to achieve "check -in, risk investigation, and rectification of problems". Click to discover one to eliminate one, persist in orderly guidance, in order to promote learning, accurately formulate rectification strategies, and strictly prevent headache and foot pain.

In the next step, the Linfen Market Supervision and Administration Bureau will systematically sort out the problems found in this inspection while doing a good job of preventing and controlling the prevention and control of the normalized epidemic. Supervision, strictly control the quality of the epidemic prevention and control of medical equipment, and use responsibility and responsibility to build a quality and safety defense line of medical device for preventing and controlling the epidemic.

Relevant staff of Yicheng County Supervision Bureau participated in the inspection.

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