医疗器械经营许可证申办流程具体解析

医疗器械经营许可证申办流程具体解析医疗器械经营许可证申办流程具体解析作为我国医疗器械产业发源地，深圳市是我国医疗器械行业的重要产业集群区域。呈现出医疗器械产业规模增长迅速、企业数量不断走高、高附加值企业占比较大、产品种类齐全、在国外市场表现活跃等特点。深圳市医疗器械产品种类齐全。

深圳医疗器械产业建立在电子产业基础之上，机电一体化产业发达且聚集程度非常高，临床诊断的新型数字成像技术、新型修复材料制备技术、重大慢病筛查诊断设备、肿瘤消融治疗设备、激光治疗设备、植介入生物医用品、植入电子治疗装置、新一代组织诱导性组织工程产品、数字化手术设备、体外诊断设备及试剂等得到快速发展。

at present，深圳医疗器械行业几乎覆盖了临床医学的所有领域，主要集中在医学影像诊断类、放射治疗类、医用电子仪器类、介入治疗类、口腔义齿类和体外诊断试剂类产品。什么是医疗器械经营许可证？医疗器械许可证是医疗器械经营企业必须具备的证件。医疗器械经营许可证分为3类。

1. The first category refers to，Regular management is sufficient to ensure its security、effectiveness of medical devices。Basic surgical knives "Scalpel handle and blade、Skin grafting knife、wart peeling knife、lancet、Blade、razor、dandruff scraper、Pick a knife、sharp knife、Shukyakuto、manicure knife、解剖刀等》
2. The second category refers to，to its security、Medical devices whose effectiveness should be controlled。

General diagnostic equipment：thermometer、sphygmomanometer;物理治疗及康复设备类磁疗器具;临床检验分析仪器：Home-use blood glucose analyzer and test strips;operating room、emergency room、Clinic equipment and appliances：Medical small oxygen concentrator portable oxygen generator;Medical hygiene materials and dressings：Use absorbent cotton、Medical skim gauze;Medical polymer materials and products：condom、避孕帽等3、The third category refers to，Implanted into human body;for support、sustain life;Potentially dangerous to human body，to its security、Medical devices whose effectiveness must be strictly controlled。

次性使用滴定管式输液器。B、骨科植入物医疗器械1、surgical implant joint prosthesis;(Disposable sterile medical devices、hearing aid、Contact lenses and care solutions、In vitro diagnostic reagents、Implant materials and artificial organs、Except for interventional devices)等办理医疗器械经营许可证的条件有哪些？

Business premises、Warehouse area

Require

：

1. Business Category II、Class III medical device products，The usable area of ​​the business premises should be no less than 40 square meters，The usable area of ​​the business premises of a branch of a legal entity shall be no less than 25 square meters.(Except for those set up across districts and cities);Dealer of hearing aids，The usable area of ​​the business premises should not be less than 25 square meters;Those who deal in contact lenses and care solutions，The usable area of ​​the business premises should not be less than 10 square meters。
2. Business Category II、Class III medical devices(hearing aid、Contact lenses and care solutions、Disposable sterile medical device products in vitro diagnostic reagents、6846Implant materials and artificial organs、6877Except for interventional devices)，The usable area of ​​the warehouse should be no less than 30 square meters;Dealing in disposable sterile medical equipment，The warehouse should be in the same building，The usable area should be no less than 200 square meters。
3. Legal entity branch(Except for those established across districts and cities)and those specializing in medical devices and equipment，No need to set up a separate warehouse，However, it should be a legal entity or a manufacturer authorized to operate products.(Including import general agent)Unified procurement and distribution of original seals、Unified quality management、Commitments such as installation and after-sales service，And the registration certificate of the specialized products、Authorization documents and other proofs。
4. Dealing in hearing aids or contact lenses and their care solutions，No need to set up a warehouse，But there should be a special counter for storage。
5. In principle, the declared business premises and warehouse shall be located nearby within the same administrative area.，and shall not be located in residential buildings、force、public security、Inside the armed police camp。

医疗器械经营许可证企业人员资质的

Require

：1.Operating third-class medical device products，quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management(medical device、biomedical engineering、mechanical、Electronics, etc.)College degree or above or intermediate technical title or above in related majors。

Dealing in disposable sterile medical equipment,There should also be at least one internal auditor holding a medical device quality management system internal auditor certificate.(The quality manager shall not concurrently serve as)。

1. Those operating Class II medical device products，quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management(medical device、biomedical engineering、mechanical、Electronics, etc.)Technical secondary school degree or above or junior technical title or above in related majors。
2. Business Category II、Class III medical device products，Technical training and after-sales service personnel(medical device、biomedical engineering、mechanical、electronic)etc. should have a technical secondary school degree or above or a junior technical title or above in a major related to the products they operate.。
3. Those who deal in hearing aids or contact lenses and care solutions，The quality manager shall be a third-party organization recognized by the state or a production enterprise authorized to operate.(Including import general agent)Contact lens fitting technology training。
4. Quality managers and heads of quality organizations are not allowed to hold concurrent jobs。办理医疗器械经营许可证的材料有哪些？
5. Copy of business license。
6. ID card of enterprise quality management personnel、学历或者职称证明及个人简历。
7. 企业组织机构与职能。
8. 企业注册地址、Geographical location map of warehouse address、floor plan、House ownership certificate。
9. 企业产品质量管理制度文件及存储设施、Device catalog。
10. 企业经营范围。医疗器械经营企业违规有啥处罚?医疗器械经营企业擅自变更质量管理人员的，Depend on(food)药品监督管理部门责令限期改正。

逾期拒不改正的，处以5000元以上1万元以下罚款。医疗器械经营企业擅自变更注册地址、仓库地址的，Depend on(food)药品监督管理部门责令限期改正，予以通报批评，并处5000元以上2万元以下罚款。

医疗器械经营企业擅自扩大经营范围、降低经营条件的，Depend on(food)药品监督管理部门责令限期改正，予以通报批评，and a fine of not less than 10,000 yuan but not more than 20,000 yuan。

申请人隐瞒有关情况或者提供虚假材料申请医疗器械经营企业许可证的，Province、autonomous region、municipality(food)The drug regulatory department or the districted municipality that accepts the entrustment(food)药品监督管理机构对申请不予受理或者不予核发医疗器械经营企业许可证，and give warning。申请人在1年内不得再次申请医疗器械经营企业许可证。

The applicant deceived、贿赂等不正当手段取得医疗器械经营企业许可证的，(food)药品监督管理部门应当撤销其医疗器械经营企业许可证》，give warning，and a fine of not less than 10,000 yuan but not more than 20,000 yuan。申请人在3年内不得再次申请医疗器械经营企业许可证。

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