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    Home > Medical News > Medical World News > The production and sale of medical devices may be traceable throughout

    The production and sale of medical devices may be traceable throughout

    • Last Update: 2021-02-04
    • Source: Internet
    • Author: User
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    On January 16, the website of the State Food and Drug Administration issued a newly revised Code of Quality Management for the Production of Medical Devices (GMP for Medical Devices), which will come into effect on March 1, 2015.
    , the new Code emphasizes that medical device manufacturers should establish and improve traceability procedures for their products, compared with the Medical Device Manufacturing Quality Management Code (Trial) issued in 2009.
    the new Code requires that enterprises should produce in accordance with the established quality management system and establish traceability procedures for products. In terms of quality control, each batch (Taiwan) product should have an inspection record and meet the requirements for traceability, and the inspection record should include inspection records, inspection reports or certificates for in-stock inspection, process inspection and finished product inspection.
    The new Code stipulates that in the sales and after-sales service, enterprises shall establish a product sales record and meet the traceability requirements, and the sales record shall include at least the name, specification, model, quantity, production lot number, expiration date, date of sale, name, address, contact information and so on. At the same time, enterprises shall establish a monitoring system for adverse events of medical devices in accordance with the relevant regulations, carry out the monitoring and re-evaluation of adverse events, and maintain relevant records; (Health News)
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