Recently, the State Food and Drug Administration issued a reply to the Hebei Food and Drug Administration's "Request for the Relevant Issues Concerning the Recording of In Vitro Diagnostic Reagents for Blood Glucose Test Strips" (冀食è¯ç›‘ [2016] No. 32). Repeat as follows:
1. Article 34 of the Measures for the Supervision and Administration of Medical Device Operation (Order No. 8 of the State Food and Drug Administration): Medical device operating enterprises shall take effective measures to ensure that the medical device transportation and storage process conforms to medical device specifications or labels. Mark the requirements and make corresponding records to ensure the quality and safety of medical devices. Where the instructions and labeling requirements are low temperature and refrigerated, they shall be transported and stored in low temperature and cold storage facilities in accordance with relevant regulations. Therefore, businesses that do not require low temperature, refrigerated transport and storage of medical devices may not be equipped with cold chain transport and storage equipment.
2. Article 12 of the "Quality Management Standards for Medical Device Management" (No. 58 of the State Food and Drug Administration announced in 2014) stipulates that one of the quality management personnel engaged in in vitro diagnostic reagents shall have one person as the competent inspector or have He has more than 3 years of work experience in inspection and related majors. Therefore, the quality management personnel of enterprises engaged in the operation of in vitro diagnostic reagents should meet the above requirements.
Third, according to the recommendations of your bureau and the actual situation, the medical device production and operation permit (recording) information system has been adjusted. For enterprises that apply for permission or record for clinical laboratory analysis instruments and diagnostic reagents, they can choose from the “business scope†of the medical device production and operation license (recording) information system: 6840 clinical test analysis instruments and diagnostic reagents (diagnostic reagents need low temperature) Refrigerated transport storage); 6840 clinical test analysis instruments and diagnostic reagents (diagnostic reagents do not require cryopreservation transport storage); 6840 clinical test analysis instruments and diagnostic reagents (excluding diagnostic reagents).
General Office of Food and Drug Administration
August 29, 2016
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