医疗器械法律法规知识培训考核试题

医疗器械法律法规知识 培训 焊锡培训资料ppt免费下载焊接培训教程 ppt 下载特设培训下载班长管理培训下载培训时间表下载 考核试题 医疗器械法律法规知识培训考核试题(1) 姓 名 部门 总分 一、填空题(每空1分 共计22分) 1(国家对医疗器械实行分类注册管理,境内第一类医疗器械由( ) 核发注册证。 2(中华人民共和国产品质量法规定，生产者、销售者依照本法规定承担( )责任。销售者应当建立并执行进货( ) 制度 关于办公室下班关闭电源制度矿山事故隐患举报和奖励制度制度下载人事管理制度doc盘点制度下载 ，验明产品合格证明和其他标识。 3. 为了加强对医疗器械的监督管理，保证医疗器械的( )，保障( )健康和( )安全，制定《医疗器械监督管理条例》。在中华人民共和国境内从事( )的研制、生产、经营、使用、监督管理的单位或者个人，应当遵守本条例。 4. 国家对医疗器械实行产品( )制度，共分( )类医疗器械。 . 生产医疗器械，应当符合医疗器械( )标准;没有( )标准的，应当符合医疗器械( )标准。医疗5 器械的( )应当符合国家有关标准或者规定。医疗器械及其外包装上应当按照国务院药品监督管理部门的规定，标明( )编号。 6. 《医疗器械经营企业许可证》有效期( )年，有效期届满应当重新审查发证。 7. 国家( )主管全国《医疗器械经营企业许可证》的监督管理工作。《医疗器械经营企 业许可证》( )及监督管理适用《医疗器械经营企业许可证 管理办法 关于高温津贴发放的管理办法稽核管理办法下载并购贷款管理办法下载商业信用卡管理办法下载处方管理办法word下载 》。 8. 医疗器械的研制、生产、经营和使用应符合相应的( )标准、( )标准或( )标准。无 相应标准的医疗器械，不得( )和( )。 二、单项选择题(每题2分，共计8分) 1、国家对医疗器械实行分类注册管理,境内第三类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 2、国家对医疗器械实行分类注册管理,境外第二类、第三类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to 3、国家对医疗器械实行分类注册管理,境内第一类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 4、国家对医疗器械实行分类注册管理,境内第二类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 5、国家对医疗器械实行分类注册管理,境外第一类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 、《医疗器械经营企业许可证》登记事项变更的，应当在工商行政管理部门核准变更后( )内，向药6 品监督管理部门申请变更登记。 A、10日 B、20日 C、30日 D、60日 三、多项选择题(每题5分，共计15分) 1、要建立医疗器械不良事件监测 报告 软件系统测试报告下载sgs报告如何下载关于路面塌陷情况报告535n,sgs报告怎么下载竣工报告下载 制度的原因是( )。 A、为了进一步了解医疗器械不良事件的情况 B、及时发现新的、严重的不良事件。 C、以便器械监督部门及时对有关器械加强管理。 D、避免同样的不良事件重复发生，保护更多人的用械安全和身体健康。 2、医疗器械不良事件监测有哪些意义( )。 A、为医疗器械监督管理部门提供监管依据。 B、可以减少或者避免同类医疗器械不良事件的重复发生。 C、降低患者、医务人员和其他人员使用医疗器械的风险，保障广大人民群众用械安全。 D、进一步提高对医疗器械性能和功能的要求。 E、推进企业对新产品的研制。 3、《医疗器械经营企业许可证》登记事项变更包括( )。 A、企业名称。 Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to B、法定代 表 关于同志近三年现实表现材料材料类招标技术评分表图表与交易pdf视力表打印pdf用图表说话 pdf 人。 C、企业负责人。 D、售后服务人。 四、名词解释(每题5分 共计15分) 1. 医疗器械: 2. 医疗器械标准国家标准或行业标准: 3. 医疗器械注册产品标准: 五、问答题(每题10分 共计40分) 1(医疗器械经营企业应当符合下列条件: 2(国家对医疗器械实行分类管理: 3. 医疗器械使用期限规定: 4. 医疗器械使用目的规定: Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to 医疗器械知识培训考核试题答案 姓 名 部门 总分 一、填空题(每空1分 共计22分) 1(国家对医疗器械实行分类注册管理,境内第一类医疗器械由( 设区的市级(食品)药品监督管理机构 ) 核发注册证。 2(中华人民共和国产品质量法规定，生产者、销售者依照本法规定承担(产品质量)责任。销售者应当 建立并执行进货检查验收制度，验明产品合格证明和其他标识。 3. 为了加强对医疗器械的监督管理，保证医疗器械的安全、有效，保障人体健康和生命安全，制定《医疗器械监督管理条例》。在中华人民共和国境内从事医疗器械的研制、生产、经营、使用、监督管理的单位或者个人，应当遵守本条例。 4. 国家对医疗器械实行产品生产注册制度，共分三类医疗器械。 5. 生产医疗器械，应当符合医疗器械国家标准;没有国家标准的，应当符合医疗器械行业标准。医疗器械的使用说明书、标签、包装应当符合国家有关标准或者规定。医疗器械及其外包装上应当按照国务院药品监督管理部门的规定，标明产品注册证书编号。 6. 《医疗器械经营企业许可证》有效期5年，有效期届满应当重新审查发证。 7. 国家食品药品监督管理局主管全国《医疗器械经营企业许可证》的监督管理工作。《医疗器械经营企 业许可证》发证、换证、变更及监督管理适用《医疗器械经营企业许可证管理办法》。 8. 医疗器械的研制、生产、经营和使用应符合相应的国家标准、行业标准或注册产品标准。无相应标准 的医疗器械，不得生产、经营和使用。 二、选择题 1、国家对医疗器械实行分类注册管理,境内第三类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 参考答案:C 2、国家对医疗器械实行分类注册管理,境外第二类、第三类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to 3、国家对医疗器械实行分类注册管理,境内第一类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 参考答案:A 4、国家对医疗器械实行分类注册管理,境内第二类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 参考答案:B 5、国家对医疗器械实行分类注册管理,境外第一类医疗器械由( )核发注册证。 A、由设区的市级(食品)药品监督管理机构。 B、由省、自治区、直辖市(食品)药品监督管理部门。 C、由国家食品药品监督管理局。 参考答案:C 6、《医疗器械经营企业许可证》登记事项变更的，应当在工商行政管理部门核准变更后( )内，向药 品监督管理部门申请变更登记。 A、10日 B、20日 C、30日 D、60日 参考答案:C 三、多项选择题(每题 1、要建立医疗器械不良事件监测报告制度的原因是( )。 A、为了进一步了解医疗器械不良事件的情况 B、及时发现新的、严重的不良事件。 C、以便器械监督部门及时对有关器械加强管理。 D、避免同样的不良事件重复发生，保护更多人的用械安全和身体健康。 参考答案:ACD 2、医疗器械不良事件监测有哪些意义( )。 A、为医疗器械监督管理部门提供监管依据。 B、可以减少或者避免同类医疗器械不良事件的重复发生。 C、降低患者、医务人员和其他人员使用医疗器械的风险，保障广大人民群众用械安全。 D、进一步提高对医疗器械性能和功能的要求。 Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to E、推进企业对新产品的研制。 参考答案:ACDE 3、《医疗器械经营企业许可证》登记事项变更包括( )。 A、企业名称。 B、法定代表人。 C、企业负责人。 D、售后服务人。 参考答案:ABC 四、 名词解释(每题5分 共计15分) 1. 医疗器械:是指单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品，包括所需要的软 件。 2. 医疗器械标准国家标准或行业标准:是指需要在全国范围内统一技术要求的标准。 3. 医疗器械注册产品标准:是指由制造商制定，应能保证产品安全有效，并在产品申请注册时，经设区 的市级以上药品监督管理部门依据国家标准和行业标准相关要求复核的产品标准。 四、 问答题(每题10分 共计40分) 1(医疗器械经营企业应当符合下列条件: (一)具有与其经营的医疗器械相适应的经营场地及环境; (二)具有与其经营的医疗器械相适应的质量检验人员; (三)具有与其经营的医疗器械产品相适应的技术培训、维修等售后服务能力。 2(国家对医疗器械实行分类管理: 第一类是指，通过常规管理足以保证其安全性、有效性的医疗器械。 第二类是指，对其安全性、有效性应当加以控制的医疗器械。 第三类是指，植入人体;用于支持、维持生命;对人体具有潜在危险，对其安全性、有 效 性必须严格控制的医疗器械。 3. 医疗器械使用期限规定: 1(暂时:器械预期的连续使用时间在24小时以内; 2(短期:器械预期的连续使用时间在24小时以上30日以内; 3(长期:器械预期的连续使用时间超过30日; 4(连续使用时间:器械按预期目的，没有间断地实际发生作用的时间。 4. 医疗器械使用目的规定: (一)疾病的预防、诊断、治疗、监护或者缓解。 (二)损伤或残疾的诊断、治疗、监护、缓解或者补偿。 (三)解剖或生理过程的研究、替代或者调节。 (四)妊娠控制。 Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to 其用于人体体表及体内的作用不是用药理学、免疫学或代谢的手段获得，但可能有这些手段参与并起 一定辅助作用。 Investigation Detachment led the development of a small crime scene simple inspection process, as much as possible to the grassroots police burden, and the inspection results into the intelligence synthetic judgments, better service. Three is to adhere to the community operation to the police. The police insist on insufficient manpower, at all levels and the police should actively launched the peace volunteer participation Publicity and public security prevention, public security mediation and so on. In order to use auxiliary police force to help do a good job of urban and rural security patrols, contradictions and disputes mediation work. To the police station area as a unit, and actively seek the party, government and village home, support the increased prevention and treatment efforts, the social forces organized, make up for the shortage of police. A service attitude, one is key in the leadership. Leadership to make an example, if leaders don't take the lead, it is driven by the team. The second is to do a good job of education. Public security work all is for the people to strengthen the education of the mass line, really establish the concept of the masses, correct attitude towards the masses. The third is to improve service Do not attract the excellent service attitude assessment activities. In the city's public security organs to carry out police service attitude assessment activities, service attitude is not good can't Pingxian tree, can not promote reuse. To practice the "immediately". "Break through the park, cohesion is the municipal Party committee, municipal government made a major strategic deployment, at all levels of public security organs should resolutely abandon everything and accelerate the development to