第1类:
是风险程度低,实行常规管理可以保证其安全、有效的医疗器械。比如手术刀、手术剪、纱布绷带、医用冰袋、听诊器等。
第2类:
是具有中度风险,需要严格控制管理以保证其安全、有效的医疗器械。比如我们日常生活中常见的体温计、血压计、心电图仪、雾化器等。
第3类:
是具有较高风险,需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。比如常见的销售xinguan实际检测盒、隐形眼镜、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等。
医疗器械经营许可证现为后置审批,有效期为5年。有效期届满需要延续的,依照有关行政许可的法律规定办理延续手续。
一、三类医疗器知械许可证注册所需材料
1、企业名称与经营范围,注册资本及股东出资比例,股东等身份证明;
2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
3、质量管理文件等;
4、2个或以上医学專业或相关專业人员证书、身份证明与简历;
5、符合医疗器械经营要求的办公场地及仓库证明;
6、公司章程、股东会决议等;
7、财务人员身份证和上岗证;
8、其它相道关材料。
nd the implementation of routine management can ensure its safeand effective medical devices. Such as scalpel, surgical scissors,gauze bandages, medical ice packs, stethoscope, etc. Category 2: Itis a medical device with moderate risk and needs strict control andmanagement to ensure its safety and effectiveness. For example, inour daily life, the common thermometer, sphygmomanometer,electrocardiogram instrument, atomizer and so on. Category 3: It isa medical device with high risk and needs to take special measuresto strictly control and manage it to ensure its safety andeffectiveness. For example, the common sales of COVID actual testboxes, contact lenses, syringe, intravenous indwelling needles,heart stents, ventilators, CT, nuclear magnetic resonance, etc. Themedical device business license is now post-approval and valid for5 years. If the term of validity needs to be extended upon theexpiration of the term, the extension procedures shall be handledin accordance with the relevant legal provisions of theadministrative license. 1. Materials required for the registrationof class III medical e knowledge and e license 1.Enterprise name and business scope, registered capital and theproportion of shareholder contribution, shareholders and otheridentity certificates; 2. Medical device product registrationcertificate, supplier business license, license and authorizationletter; 3. management documents, etc.; 4,2 or morecertificates, identification certificate and resume of medicalprofessionals or related professionals; 5. Office space andwarehouse certificate that meet the business requi