Q：
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What conditions shall meet when apply for Medical Instrument Operation License?
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A：
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To apply for Medical Instrument Operation License, the following conditions shall be met:
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Quality management institutions or quality management personnel suitable for business scope and business scale, and quality management personnel shall have relevant professional qualifications or professional titles;
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Business sites suitable for business scope and business scale;
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Storage conditions suitable for business scope and business scale;
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Quality management system suitable for operating medical instruments;
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Quality management institutions or personnel for professional guidance, technical training and after-sales service that are suitable for operating medical instruments;
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Have a computer information management system that meets the requirements of the medical instrument operation quality management system.
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Q：
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What materials are required for applying for the Medical Instrument Operation?
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A：
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An enterprise applying for Instrument Operation License shall submit the following materials to the local drug regulatory department:
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Copies of relevant materials such as the identity certificate, educational background or professional title of the legal representative (person in charge of the enterprise) and the person in charge of quality;
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Enterprise organization and department setting;
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Medical instrument business scope and business mode;
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Copies of geographical map, floor plan, property title documents or lease agreement of the business premises and warehouse;
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List of main operating facilities and equipment;
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List of documents such as operation quality management system and work procedures;
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Basic situation of information management system;
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Authorization document of handler.
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Q：
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What should the enterprise do when Medical Instrument Operation License is going to expire?
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A：
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When the validity of the Medical Instrument Operation License expires, an application for extension shall be submitted within 90 to 30 working days before the expiration of the validity. If no extension application is submitted within the time limit, the extension application shall not be accepted.
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Q：
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What are the changes in the Medical Instrument Operation License after the extension?
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A：
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The license number of the extended Medical Device Business License remains unchanged. If the approval time for the extension of the license is within the validity period of the original license, the start date of the extension shall be the day following the expiry date of the original license; if the approval time is not within the validity period of the original license, the start date of the extension shall be the date on which the extension of the license is approved.
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Q：
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What should the enterprise do if the Medical Instrument Operation License is lost?
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A：
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If the Medical Instrument Operation License is lost, it shall apply to the original issuing department for reissuance. The original license-issuing department shall reissue the Medical Instrument Operation License in a timely manner, and the number and validity period of the reissued Medical Instrument Operation License shall be consistent with the original license.
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FAQ
