深圳第三类医疗器械经营许可证申请条件、Material

深圳第三类医疗器械经营许可证

Application conditions

、材料深圳深圳第三类医疗器械经营许可证怎么办理？办理第三类医疗器械经营许可证的

Application conditions

是什么？办理第三类医疗器械经营许可证的申请材料有哪些？这些问题今天为大家来解答，There’s also reading consultation! ! !

第三类医疗器械经营许可证申请资料：符合相关

Require

和法定形式，同时具备下列条件的，予以审批。(1) Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；

1. Have a relatively independent business location that is commensurate with the business scale and scope of business；
2. Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices

Require

storage facilities、equipment；

1. A sound product quality management system should be established，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking system and adverse event reporting system, etc.；
2. Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support。

第三类医疗器械经营许可证办理材料：formal standards：1.Application materials should be complete、clear，

Require

签字的须签字，加盖企业公章，使用A4纸打印或复印，按照申请材料顺序装订成册；

1. All application materials need to be submitted with copies，申请人须在复印件上注明日期，加盖企业公章；
2. 申报资料应当使用中文，根据外文资料翻译的申报资料，应当同时提供原文。

申请材料列表：

1. 《深圳市医疗器械经营企业许可证申请表》；
2. 《医疗器械经营企业许可证申请材料登记表》；
3. 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(Verify original)；
4. 拟办企业质量管理负责人的身份证、Copies of academic qualifications or professional title certificates and resume；
5. ID card of the quality management personnel of the proposed enterprise、Copy of academic qualification or professional title certificate；
6. The organizational structure and functions of the proposed enterprise or the functions of full-time quality management personnel；
7. 拟办企业注册地、仓库的地理位置图、floor plan(Indicate area)、房屋产权证明或者租赁协议(附租赁房屋产权证明，The same below)a copy；
8. 拟办企业产品质量管理制度文件及储存设施、Device catalog。

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