Q：
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What items are contained in the Medical Instrument Operation License?
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A：
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The Medical Instrument Operation License contains the license number, enterprise name, unified social credit code, legal representative, person in charge of the enterprise, address, business address, business mode, business scope, warehouse address, issuing department, issuing date and validity period, etc.
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Q：
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How to change the Medical Instrument Operation License?
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A：
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If the items contained in the Medical Instrument Operation License are changed, the enterprise shall apply to the original license-issuing department for the change of the Medical Instrument Operation License, and submit the relevant materials related to the changed item.
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Q：
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How long does it take to change the business scope of the Medical Instrument Operation License?
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A：
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If the business address, business mode, business scope and warehouse address of a Medical Instrument Operation License are changed, the drug regulatory department shall decide within 20 working days from the date of acceptance. If necessary, conduct on-site inspections in accordance with the requirements of the medical device business quality management specification.
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Q：
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How long does it take to change the enterprise name of the Medical Instrument Operation License?
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A：
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If other items other than the business address, business mode, business scope, and warehouse address are changed, the drug regulatory department shall make changes on the spot.
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Q：
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Is it necessary to change the Medical Instrument Operation License for the newly established business address of the medical instrument business enterprise?
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A：
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If a medical instrument business enterprise establishes a new independent business address, it shall separately apply for a Medical Instrument Operation License or filing it according to the law.
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FAQ
