Q：
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What is the Medical Instrument Operation License?
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A：
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The Medical Instrument Operation License is the legal certificate that enterprises engaged in the business activities of Class III medical instruments should obtain according to law.
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Q：
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Do enterprises engaged in the business activities of other classes medical instruments need to apply for a Medical Instrument Operation License?
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A：
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According to the risk level of medical instruments, the business of medical instruments shall be managed by classification. The business of Class III medical instruments is subject to licensing management, the business of Class II medical instruments is subject to filing management, and the business of Class I medical instruments does not require license and filing.
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Q：
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How long is the validity period of Medical Instrument Operation License?
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A：
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5 years.
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Q：
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Which enterprises need to apply for Medical Instrument Operation License?
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A：
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Enterprises engaged in the business of Class III medical instruments shall obtain the Medical Instrument Operation License according to law with the approval of the drug regulatory department of the province, autonomous region, or municipality directly under the central government where it is located.
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Q：
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How long does it take to apply for the Medical Instrument Operation License?
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A：
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The drug regulatory department shall review the application documents, conduct on-site inspections in accordance with the requirements of the medical device business quality management standard if necessary, and decide within 20 working days from the date of acceptance of the application. If rectification is required, the rectification time is not included in the review time limit. If the specified conditions are met, a written decision to grant the license shall be made according to law, and the Medical Instrument Operation License will be issued within 10 working days.
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FAQ
