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    Home > Medical News > Medical World News > National Medical Device Quality Bulletin (No. 6 of 2016, No. 14)

    National Medical Device Quality Bulletin (No. 6 of 2016, No. 14)

    • Last Update: 2021-02-08
    • Source: Internet
    • Author: User
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    In order to strengthen the supervision and management of the quality of medical devices and ensure the safe and effective use of medical device products, the State Administration of Food and Drug Administration organized quality supervision and testing of 206 batches (taiwan) of 3 varieties of products, such as Type B ultrasound diagnostic equipment, natural latex rubber condoms and disposable intravenous retention needles. The results of the test will now be announced as follows:
    1, the items tested do not meet the standards of medical device products, involving 4 medical device production enterprises 2 varieties of 4 batches (Taiwan). Specifically:
    (1) B-type ultrasound diagnostic equipment 1 enterprise 1 product. Chongqing Boenfuk Medical Equipment Co. , Ltd. produced a full-digital ultrasound diagnostic device, input power does not meet the standard requirements.
    (ii) one-time use of venous retention needles 3 enterprises 3 batches of products. Xinxiang City Camel Medical Devices Co. , Ltd. produced a batch of disposable use of venous retention needles, seat does not meet the standard requirements; Jiangxi Huali Medical Devices Co., Ltd. production of 1 batch of dynamic venous retention needles (anti-counterflow type 2), ethylene oxide residue does not meet the standard requirements;
    of products that do not meet the requirements of the above tests are set out in Annex 1.
    , the items tested for identification labels, instructions and other items do not meet the standards of medical device products, involving 3 medical device manufacturers of 1 variety of 3 units, specifically:
    Type B ultrasound diagnostic equipment 3 enterprises 3 products. Xuzhou Bells Electronic Technology Co., Ltd. produced a full-digital color Doppler ultrasound diagnostic instrument, technical instructions do not meet the standards, Shenzhen Kaivor Electronics Co., Ltd. produced a B-type ultrasound diagnostic instrument, Shenzhen Besta Medical Co., Ltd. produced a full-digital color ultrasound diagnostic system, identification, marking and documentation does not meet the standards.
    of products that do not meet the requirements of the above-above tests are set out in Annex 2.
    , the test items all meet the standards of medical device products involving 76 medical device manufacturers of 3 varieties 199 batches (Taiwan), the specific situation see Annex 3.
    . With regard to the products found in the above-mentioned tests that do not meet the standards, the State Food and Drug Administration has requested the food and drug supervision and administration departments where the enterprises are located to investigate and deal with the relevant enterprises in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Notice of the State Food and Drug Administration on Further Strengthening the Work of Medical Devices Testing (No. 9 of the Food and Drug Administration).
    relevant medical device manufacturers shall conduct a risk assessment of products that do not meet the standards and items that do not meet the standards, determine the recall level according to the severity of the medical device defects, and the enterprises shall voluntarily recall and disclose the recall information. The food and drug supervision and administration department where the enterprise is located shall supervise the recall of the enterprise, and those who have not organized the recall shall be ordered to recall; if they are found to have caused harm to human health by medical device products that do not conform to the standards or have evidence that they may endanger human health, emergency control measures may be taken to suspend production, import, operation and use.
    relevant provincial food and drug supervision and administration departments should urge enterprises to find out the cause as soon as possible, formulate corrective measures and put them in place on time, and the relevant disposal situation shall be announced to the public by September 30, 2016.
    this announcement. (State Administration of Food and Drug Administration)
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