Q：
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What conditions shall meet when apply for Medical Instrument Production License?
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A：
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To apply for Medical Instrument Production License, the following conditions shall be met:
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With production sites, environmental conditions, production equipment and professional technicians that are suitable for the production of medical instruments;
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With institutions or full-time inspectors and inspection equipment that can conduct quality inspection of the medical instruments produced;
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With a management system to ensure the quality of medical instruments;
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Have after-sales service capabilities that are compatible with the medical instruments produced;
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Meet the requirements of regulations of product development and production process documents.
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Q：
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What materials are required for applying for the Medical Instrument Production?
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A：
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An enterprise applying for Instrument Production License shall submit the following materials to the local drug regulatory department:
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Copies of the registration certificate of the medical instrument produced and product technical requirements;
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Copy of the identity certificate of the legal representative (person in charge of the enterprise);
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Copies of the identity, academic qualification and professional title of the person in charge of production, quality and technology;
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List of academic qualifications and professional titles of employees in production management and quality inspection positions;
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Copies of relevant documents of the production site, if there are special production environment requirements, copies of relevant documents of facilities and environment shall also be submitted;
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Catalogue of main production equipment and inspection equipment;
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Quality manual and catalogue of procedure documents;
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Production flow chart;
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Relevant materials proving the ability of after-sales service;
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The authorization document of the handling personnel.
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Q：
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What should the enterprise do when Medical Instrument Production License is going to expire?
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A：
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When the validity of the Medical Instrument Production 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 should the enterprise do if the Medical Instrument Production License is lost?
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A：
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If the Medical Instrument Production License is lost, it shall apply to the original issuing department for reissuance. The original license-issuing department shall reissue the Medical Instrument Production License in a timely manner, and the number and validity period of the reissued Medical Instrument Production License shall be consistent with the original license.
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Q：
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How to change Medical Instrument Production License?
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A：
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The change of Medical Instrument Production License is divided into the change of permitted items and the change of registration items. The change of licensed items refers to the change of the production scope and production address; the change of registration items refers to the change of enterprise name, legal representative (person in charge of the enterprise), registered address, literal change of production address and reduction in production scope.
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FAQ
