Release date: 2013-05-13
Recently, the Huangshan Municipal Bureau highlighted the "four key points" to ensure the quality of medical devices.
First, the legal standards for strict inspection procedures. Strictly implement the “National Medical Device Quality Supervision and Inspection Management Regulations (Trial)†in the sampling inspection work. Law enforcement personnel carefully check the specifications, model, date of manufacture, etc., and sample the samples for on-site sealing to ensure sample integrity and sampling. Fairness.
The second is to strictly check the relevant materials of medical equipment. The law enforcement personnel conducted on-site inspections on the relevant licenses, registration standards, production (purchase) sales records, production (purchase) sales vouchers, establishment and implementation of the quality inspection system for sampling inspections. If the relevant enterprises fail to comply with the relevant systems, the law enforcement personnel will propose rectification opinions, requiring the relevant enterprises to strengthen the study of medical device laws and regulations, and continuously improve the sense of responsibility and management of the enterprise.
The third is to strictly meet the sampling coverage of equipment. In combination with the daily supervision and inspection, in the premise of highlighting the focus of medical device testing in the city in 2013, and successfully completing the medical device sampling task, the medical device management enterprise and the medical institution are reasonably allocated specific sampling quantities to improve the supervision efficiency of the medical device market.
The fourth is to combine with the H7N9 bird flu epidemic prevention and control work. In the sampling test, the supervision and control of medical devices related to H7N9 avian influenza is regarded as an important task of supervision, and relevant certificates, registration approvals, and certificates of conformity for the prevention and control of medical devices are verified. (From the website of Anhui Provincial Food and Drug Administration)
Source: vCount:
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