广东新法规《医疗器械注册证》登记事项变更.doc

the partys fine style, carry forward the traditional Chinese virtues, practicing the Socialist core values, vigorously carry forward the spirit of Jiao Yulu, Hongqi Canal spirit and spirit of persistence, honesty in politics, strict statesman, stick to the spiritual heights of the Communists. Four to devotion, as, do play a role in qualifying. Official Communist duty. To fulfill the partys purpose, maintain for the people themselves, and dedication, devotion, maintain pioneer, pioneering and enterprising spirit, active at the well-off extra practice, make contributions. The incentive function of party organizations at all levels should give full play to advanced models, establish a representative, advanced and typical of the times, and guide the broad masses of party members to emulate. In honor of the 95 anniversary of founding as an opportunity to award in recognition of a number of outstanding party members advanced grass-roots party organizations, outstanding party workers, and put the pioneer trees. Third, the reform efforts for example, be sure to change into. Learning to teachEducation in order to solve the problem, if it does not solve the problem, it will form, goes through the motions. To strengthen the consciousness of problems and insisted on problem-oriented, problem-solving learning education for traction, truly deep investigation into change, modification. A checked swing. Learning education programme for party-building in our city actually proposed to focus on solution of fuzzy ideals and beliefs waver, consciousness, purpose of the party weak sense, honesty and self-discipline awareness is not strong, depressed, six issues of ethical misconduct study contents specific programmes for all party members and leading cadres above the county level shall focus on further refinement to the problems. Specific to every party member and every cadre, also requires a combination of actual and controlled, focused and really put yourself in, people see things, see, with their own specific problems to learn Constitution Party rules, series, address, so precision to find the problem, laying a solid foundation for further corrective action. B to make change. For check put of problem, through established rectification Taiwan account, and take special supervision, and on account PIN, approach, insisted do side learn side modified, and that know that modified, while focused on put two learn a do learning education rectification with grasp party of mass line education practice activities and three strict three real topic education problem rectification combined up, consolidation expanded has made of rectification results, strongly corrected for officer not for, and Chi and endless corrected four wind, and regulation masses side of abuses, ensure work advance more powerful, and problem solution more completely. Third, we must consolidate our achievements. For more public, some party members who focus on the outstanding issues, combining concentrated广东新法规医疗器械注册证登记事项变更一、行政许可项目名称：医疗器械注册证登记事项变更二、行政许可内容登记事项变更的受理及审批三、设定行政许可的法律依据：1、医疗器械监督管理条例（国务院令第650号）2、医疗器械注册管理办法（国家食品药品监督管理总局令第4号）四、行政许可数量及方式无数量限制五、行政许可条件1.广东省食品药品监督管理局核发的二类医疗器械注册证，注册证及其附件载明的内容发生变化。2.申请符合医疗器械注册管理办法要求。3.注册人名称和住所发生变化的，注册人应当向原注册部门申请登记事项变更；境内医疗器械生产地址变更的，注册人应当在相应的生产许可变更后办理注册登记事项变更。六、申报资料具体要求及说明（一）申请表（二）证明性文件1.企业营业执照副本复印件2.组织机构代码证复印件（三）申请人关于变更情况的声明（四）原医疗器械注册证及附件复印件、历次医疗器械注册变更文件复印件（五）关于变更情况相关的申报资料要求1.注册人名称变更：企业名称变更核准通知书（境内注册人）和/或相应详细变更情况说明及相应证明文件。2.注册人住所变更：相应详细变更情况说明及相应证明文件。3.境内医疗器械生产地址变更：应提供相应变更后的生产许可证。（六）符合性声明1.注册人声明本产品符合医疗器械注册管理办法和相关法规的要求；声明本产品符合现行国家标准、行业标准，并提供符合标准的清单；2.注册人出具所提交资料真实性的自我保证声明。七、申报资料一般要求（一）网上申报在递交书面申报材料前，应通过企业网上办事平台（43）网上申报医疗器械注册证核发的电子版申请材料，并上传相应电子版（网上申报操作指引.pdf），取得预受理号，并在1个月内提交书面申请。企业在提交纸质申请材料时须同时提交预受理号。（二）格式及其他要求1.申请材料应清晰、整洁，使用A4规格纸张打印；2.每项文件第一页作标签，或用带标签的隔页纸分隔，并按资料目录标明项目编号；3.每项文件均应加盖企业公章；4.按照申请材料目录的顺序装订成册；5.用档案袋将报送的材料装好，档案袋需使用封面，格式见“档案袋封面格式”。6.办理医疗器械注册申请事务的人员应当受申请人委托，应出示授权委托书及该办理人身份证明原件与复印件。八、申请表格及文件下载1、申请表（变更）.doc2、医疗器械注册申报资料要求及说明.doc3、医疗器械安全有效基本要求清单.doc4、授权委托书（参考样式）.doc5、资料装订.封面.目录（参考样式）.doc6、关于发布医疗器械产品技术要求编写指导原则的通告.doc7、关于进一步做好医疗器械产品分类界定工作的通知.doc8、关于印发创新医疗器械特别审批程序（试行）的通知.docx9、免于进行临床试验的第二类医疗器械目录（通告2014年第12号附件）.doc10、实施医疗器械注册管理办法和体外诊断试剂注册管理办法有关事项的通知.doc通知.doc 九、行政许可申请受理机关广东省食品药品监督管理局受理地点：广州市东风东路753号之二一楼业务受理处受理时间：每周一至周五上午9：0012：00，下午13：0017：00(逢周五下午不对外办公)十、行政许可决定机关广东省食品药品监督管理局十一、行政许可程序 十二、行政许可时限登记事项变更资料符合要求的，在10个工作日内发给医疗器械注册变更文件。十三、行政许可证件及有效期限行政许可证件：医疗器械注册变更文件。医疗器械注册变更文件与原医疗器械注册证合并使用，其有效期与该注册证相同。取得注册变更文件后，注册人应当根据变更内容自行修改产品技术要求、说明书和标签。十四、行政许可收费：按有关部门批准收费十五、行政许可年审或年检：无十六、咨询与投诉机构咨询：广东省食品药品监督管理局医疗器械注册处投诉：广东省食品药品监督管理局政策法规处注：以上期限以工作日计算，不含法定节假日奥咨达小编提醒你，快捷医疗器械注-册、zi询、各国ren-证、体系、临-床试验等一条龙高质量服务，服-务超过2600家企业，技术过硬，成功率高。报jia？快来问问奥咨达客fu吧！将汽机PCA段电源进线开关241A摇至工作位，送上操作电源，把联锁开关2LK打至远方，在DCS操作汽机PCA段进线开关241A合闸，检查母线带电运行情况rectification and strengthening the management of daily education, the spirit of reform short of the complete system, pay close attention to system implementation, really make the party organization and party member education and strict management, solid. Finally, the urge work on the lead, be sure to promote efficiency. Two education, not on education educational, not working with the Centre two, must stick around the Center, serving the overall situation, coordinate, truly result-oriented and promote efficiency. Current and future a period, to tightly around coordination advance four a full strategy layout, winning full built society this a central and work overall, put carried out learning education as promoted work of important opportunities and powerful power, guide General members cadres insisted development first priority, active adapted economic development new normal, consciously practice line five big development concept, effective grasp supply side structural reform, to guarantees and improved livelihood, construction more high ecological vitality happiness of city. Last year, we carry out three-three activities as a three-three special education important, find education and effective platform to facilitate the combination of work. Reference this a good practices, provincial, and municipal decided in two learn a do learning education in the carried out five check five promoting, the County District units to insisted put two learn a do learning education and five check five promoting organic fusion, and common advance, do one plan layout, and one organization implementation, put carried out two learn a do situation, and five check five promoting situation as party work evaluation of importantContent, as an important aspect of mutual evaluation on party members, testing as an important basis for leading bodies and leading cadres performance and guide the broad masses of party members and cadres to study education opens up to the main economic and social development. At present, the overall smooth economic operation in our city, but downward pressure is still high, faced a number of challenges and tests. Meanwhile, coincides with the city, County and township party committees this year general election year, how to r