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丰台莲花池北京医疗器械三类经营许可证二三类专业快捷包拿证

更新时间:2023-11-04 00:00:00
价格:请来电询价
医疗器械三类:注册
医疗器械二类:注册
注册公司:网络销售备案
联系电话:15501182773
联系手机:15501182773
联系人:马胜辉
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详细介绍

、三类医疗器械经营许可证办理方式如下:
(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(3)到实际场地进行勘察以及对产品进行审核;
(4)准予颁发三类医疗器械许可证。
2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;
(四)临床评价资料;
办理三类医疗器械经营许可证的条件如下:

(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等;

(五)应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。

(六)具有与经营的医疗器械相适应的质量管理制度。

其次,经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。

(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;

(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;

medical devices is handled as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical device products and the application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) risk analysis data of product risk analysis; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; the conditions for handling the business license of Class III medical devices are as follows: (4) The product quality management system shall be established and improved, including procurement, purchase and acceptance inspection, storage, warehouse delivery review, quality tracking system and the reporting system of adverse events; (5) It shall have the ability of technical training and after-sales service suitable with the medical devices it operates. (6) It shall have a quality management system suitable for the medical devices in operation. Secondly, the operating enterprise should know what information it needs to prepare for the business license of three types of medical equipment. (1) Submit the application form for the license of the medical device operating enterprise, signed by the legal representative or affix the official seal of the enterprise; (2) The copy of the pre-approval certificate of enterprise name or the business License issued by the administrative department for industry and commerce;

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