LCLS Diagnostics and Commissioning WorkshopLCLS诊断与调试车间
以医疗器械作用为主的药械组合产品注册审查指导原则英语
以医疗器械作用为主的药械组合产品注册审查指导原则英语Guidance Principles for the Registration Review of Medical Device-Drug Combination Products1. IntroductionMedical device-drug combination products are a category of products that combine a medical device and a drug component to achieve the intended use. The registration review of such products requires a comprehensive assessment of both the device and drug components, as well as the interaction between them. This guidance outlines the key principles and considerations for the registration review of medical device-drug combination products.2. ScopeThis guidance applies to medical device-drug combination products where the device component is the primary mode of action. The principles and considerations outlined in this guidance may also be applicable to other types of combination products, such as those where the drug component is the primary mode of action.3. Regulatory FrameworkThe registration of medical device-drug combination products is subject to the regulatory requirements for both medical devices and drugs. Applicants should ensure compliance with the relevant regulations and guidelines for each component, as well as the specific requirements for combination products.4. Product Identification and ClassificationMedical device-drug combination products should be clearly identified and classified based on the primary mode of action and the intended use. Applicants should provide a detailed description of the product, including the device and drug components, their respective functions, and the intended use of the combination product.5. Quality ConsiderationsThe quality of both the device and drug components should be thoroughly evaluated. This includes the design, manufacturing, and control of the individual components, as well as the compatibility and interactions between them. Applicants should provide comprehensive information on thequality attributes, specifications, and control strategies for the combination product.6. Nonclinical EvaluationNonclinical studies should be conducted to assess the safety and performance of the combination product. This may include studies on the device-drug interaction, the local and systemic effects of the combination, and the potential for any adverse interactions or reactions.7. Clinical EvaluationClinical studies are essential to evaluate the safety and efficacy of the combination product. Applicants should design and conduct clinical trials that assess the overall performance of the combination product, including the device and drug components, and the interaction between them.8. Risk ManagementApplicants should implement a comprehensive risk management plan to identify, assess, and mitigate the potential risks associated with the combination product. This includes the risks related to the device and drugcomponents, as well as the risks arising from the interaction between them.9. Labeling and PackagingThe labeling and packaging of the combination product should provide clear and comprehensive information to healthcare professionals and patients. This includes the instructions for use, any special handling or storage requirements, and any warnings or precautions related to the combination product.10. Postmarket SurveillanceApplicants should establish a robust postmarket surveillance system to monitor the performance and safety of the combination product after it is approved for use. This includes the collection and analysis of adverse event reports, as well as the implementation of any necessary corrective or preventive actions.中文版本:医疗器械作用为主的药械组合产品注册审查指导原则1. 引言医疗器械-药物组合产品是一类将医疗器械和药物组合在一起以实现预期用途的产品。
医疗器械监督管理条例英文版
Regulations for the Supervision and Administration of Medical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety.Article 2 All units or individuals engaged in the research and development, production, distribution, use, supervision and administration of medical devices within the territory of the People's Republic of China shall comply with the Regulation.Article 3 "Medical devices" as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modification for anatomy or a physiological process;4. Control of conception.Article 4 The drug regulatory authority under the State Council is responsible for supervision and administration of medical devices nationwide. The drug administration of the local government at county level and above is responsible for supervision and administration of medical devices in each administrative region. The drug regulatory authority under the State Council shall coordinate with other departments under the State Council, responsible for comprehensive economic administration, in the implementation of policies for the medical device industry.Article 5 The State shall classify medical devices and administer them based on this classificationClass I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;Class II Medical Devices are those for which further control is required to ensure their safety and effectivenessClass III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.The classification catalogue for medical devices shall be stipulated, adjusted and promulgated by the drug regulatory authority under the State Council, in accordance with classification principles after consulting with health authority under the State Council.Article 6 Medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metering law. The detailed product list shall be formulated and promulgated by the drug regulatory authority under the State Council, jointly with the metering authority.Chapter II The Administration of Medical DevicesArticle 7 The State encourages the research and development of new medical devices. "New medical devices" refer to the kind of brand new product varieties which have not been available in the domestic market, or for which the safety, effectiveness and product mechanism have not been recognized domestically.The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council.New medical devices that have completed clinical trials and passed experts' evaluation and review organized by the drug regulatory authority under State Council, shall receive a new product certificate after being approved by the same organization.Article 8 The State shall implement a product registration system for the manufacturing of medical devices.Class I medical devices shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council.Clinical evaluation must be conducted for Class II and Class III medical devices before they are put into production.Article 9 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the inspection and approval of the clinical trial or verification of class II medical devices in their own administrative regions. The drug regulatory authority under the State Council is responsible for the inspection and approval of clinical trial or verification of class III medical devices.Clinical trial or verification shall be conducted in the medical institutions designated by the drug regulatory authorities of the government at provincial level and above. The medical institutions shall conduct the clinical trial or verification, in accordance with the related provisions of the drug regulatory authority under the StateCouncil.The qualification of medical institutions engaged in the clinical trial or verification shall be certified by the drug regulatory authority, jointly with the health authority under the State Council.Article 10 Medical institutions may develop medical devices to serve their own clinical needs, and use them within their own institution under the guidance of licensed medical practitioners.Class II medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority of the government at provincial level and above. Class III medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority under the State Council.Article 11 When importing medical devices into China for the first time, the agent of the imported device, should submit the instruction for use, quality standards, testing methods, other relevant information, product samples, and marketing authorization certificates issued by the manufacturing countries (regions), for inspection and approval by the drug regulatory authority under the State Council, and receive an import product registration certificate before applying for customs formalities.Article 12 When applying for registration of medical devices, technical standards, testing report and other relevant information shall be submitted according to provisions of the drug regulatory authority under the State Council.The drug regulatory authority of the government of the municipality consisting of districts shall decide within 30 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 60 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority under the State Council shall decide within 90 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.Article 13 In case any situation reflected in the content of the registration certificate is changed, the holder of the certificate shall apply for an amendment of the certificate accordingly, or for re-registration within 30 working days from the change.Article 14 The term of validity for the registration certificate of medical devices is four years. The holder of the certificate shall apply for re-registration within six months before the certificate expires.When the manufacturing of a medical device is stopped continuously for more than 2 years, its registrationcertificate is automatically invalidated.Article 15 Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.National standards of medical devices shall be formulated jointly by the standardization authority and the drug regulatory authority under the State Council. Professional standards of medical devices shall be formulated by the drug regulatory authority under the State Council.Article 16 The instruction for use, label and package of medical devices shall comply with relevant standards or provisions in China.Article 17 The registration number of a medical device shall be marked on the product itself and the external package according to the provisions of the drug regulatory authority under the State Council.Article 18 The State implements a system of re-evaluation and obsolescence for medical devices, the details of which shall be formulated by drug regulatory authority under the State Council after consulting with other related authorities under the State Council.Chapter III Administration of Production, Distribution and Useof Medical DevicesArticle 19 Enterprises manufacturing medical devices shall meet the following conditions:1. Possess professional technical personnel required for the manufacture of its medical devices;2. Possess facility and environment required for the manufacture of its medical devices;3. Possess equipment required for the manufacture of its medical devices;4. Possess an establishment or personnel and equipment for quality testing required for the manufacture of its medical devices.Article 20 Establishment of manufacturing of class I medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing manufacturing of class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Manufacturing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Manufacturing Enterprise License.The term of validity of the Medical Device Manufacturing Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 21 Medical device manufacturing enterprises shall not start manufacturing products before obtainingthe manufacturing enterprise license.Article 22 The State implements a mandatory safety certification system for certain class III medical devices.A specific product list shall be established by the drug regulatory authority under the State Council, jointly with the quality and technology supervision authority.Article 23 Enterprises distributing medical devices shall meet the following conditions:1. Possess appropriate facility(s) and environment for the kind of medical devices to be distributed;2. Possess appropriate quality inspection personnel for the kind of medical devices to be distributed;3. Possess adequate ability for technical training, maintenance and after-sales services for the kinds of medical devices to be distributed;Article 24 Establishing of distribution of class II and/or class III medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing an enterprise distributing class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Distributing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Distributing Enterprise License.The term of validity of the Medical Device Distribution Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 25 The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 30 working days whether the licenses for manufacturing or distributing enterprises of medical devices can be issued, counting from the date of acceptance of the application. When a license is not issued, a written explanation shall be given to the applicant.Article 26 Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Manufacturing Enterprise License or Medical Device Distribution Enterprise License, and shall verify the certificates of qualified products.Distribution enterprises shall not distribute medical devices without registration certificates or certificates for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Medical institutions shall not use medical devices without registration, or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Article 27 Medical institutions shall not re-use medical devices labeled for single use, shall destroy them after use and establish a record, according to relevant provisions of the country.Article 28 The State shall establish a quality incident reporting system and a warning system of medical devices. Implementation details shall be stipulated by the drug regulatory authority under the State Council, in conjunction with the health authority and family planning authority under the State Council.Chapter IV Supervision of Medical DevicesArticle 29 The drug regulatory authorities of governments at county level and above shall appoint medical device monitors within their organization, who are responsible for the supervision and inspection of medical device manufacturing enterprises, distribution enterprises and medical institutions within their own administrative regions. When necessary, monitors may take product samples and ask for relevant materials according to the provisions promulgated by the drug regulatory authority under the State Council. Institutions and individuals concerned shall not decline cooperation or be deceitful in the monitoring process. The monitors shall be responsible to keep collected samples and materials confidential.Article 30 The State implements an accreditation system for the qualification of the testing institutions of medical devices. Only testing institutions accredited by the drug regulatory authority in conjunction with the quality and technical supervision authority under the State Council may conduct medical device test.Medical device testing institutions and their staff members shall keep strictly confidential all technical information provided by enterprises whose products are being tested, and shall not conduct or be involved in research and development, manufacture, distribution and technical consultation related to the devices tested.Article 31 For products having caused or which may potentially cause quality incidents, the drug regulatory authority of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.Article 32 The drug regulatory authority of the governments at provincial level and above shall revoke the registration certificates of medical devices of which safety and effectiveness can not be ensured. Medical devices whose registration certificates have been revoked shall not be manufactured, distributed and used. Those already produced or imported shall be dealt with by the drug regulatory authority of government at county level and above.Article 33 The drug regulatory authorities of the government of the municipality consisting of districts and above, which perform product registrations in violation of these regulations, shall be ordered by the drug regulatory authority under the state council to correct the violations within a defined period. For those not corrected within the period, the product registration certificates may be revoked and the events may be made public.Article 34 Advertisements of medical devices shall be reviewed and approved by the drug regulatory authority of governments at provincial level and above, and shall not be published, broadcasted, circulated or posted before the approval.The contents of the advertisements shall be based on the instruction for use approved by the drug regulatory authority under the State Council or the drug regulatory authority of the governments of provinces, autonomous regions and municipalities directly under the Central Government.Chapter V PenaltiesArticle 35 In cases of manufacturing medical devices without product registration certificates, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and related illegal income. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times the total sum of the illegal income shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; in serious cases, the drug regulatory authorities of the governments at the provinces, autonomous regions and municipalities directly under the Central Government shall revoke the Medical Device Manufacturing Enterprise License; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 36 In cases of manufacturing class II and class III medical devices without a Medical Device Manufacturing Enterprise License, in violation of these regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 37 In cases of manufacturing medical devices not in conformity with national standards or professional standards for medical devices, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an warning, followed with an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the product registration certificates shall be revoked by the authorities originally issued the certificates; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 38 In cases of Distribution of class II and class III medical devices without a Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand yuan to RMB 20 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 39 In cases of distributing medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drugregulatory authority of governments at county level and above shall issue an order to stop the distribution, confiscate all of the illegally distributed products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the Medical Device Distributing Enterprise License shall be revoked by the authorities which originally issued the license; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 40 In cases where false certificates, documents, materials, or product samples are submitted in registration applications, or obtaining medical device registration certificates are obtained using other deceitful means, which violate provisions of these Regulations, the product registration certificates shall be revoked by the authorities which originally issued the certificates, and within a period of two years, other product registration applications of the violating enterprise shall not be accepted. Additionally, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; for enterprises already started manufacturing, all of the illegally manufactured products and their illegal incomes shall be confiscated; in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 41 Violation of Article 34 of these Regulations concerning provisions for advertisement of medical devices shall be dealt with by the industrial and commercial authority according to relevant laws and regulations of the country.Article 42 In cases of Medical institutions using medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violate provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction, launch a warning, and confiscate all of the illegally used products and illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed, and person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 43 In cases of medical institutions re-using devices for single use, or not destroying devices which should be destroyed, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 5 thousand to 30 thousand yuan; in serious cases, the medical institutions may be applied with a fine of RMB 30 thousand to 50 thousand yuan, and person(s) in charge and other directly responsible personnel be applied with disciplinary punishment; and in case crimes are committed, criminal liabilities shall be investigated and handled according to the law.Article 44 In cases in which medical institutions undertake clinical trials or clinical verifications of medicaldevices and provide false reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RM B 10 thousand to 30 thousand yuan；in serious cases, the qualification for clinical trial or clinical verification of medical devices shall be terminated, person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; an d in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 45 For cases in which testing institutions and their personnel are found to be conducting or involved in research and development, manufacturing, distribution and technical consultation of medical devices which are related to the testing, or establishing false testing reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 10 thousand to 30 thousand yuan; in serious cases, the qualification for testing shall be terminated by the drug regulatory authority under the State Council, person(s) in charge and other directly responsible personnel shall be receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to law.Article 46 In cases where personnel engaged in supervision and administration of medical devices abuse their power, pursue personal benefits by deceiving, or neglecting their duties, in violation of provisions of these Regulations, to the extent to which crimes are committed, criminal liabilities shall be investigated and handled according to the law. For those not committing crimes, disciplinary punishment shall be applied according to the relevant regulations.Chapter VI Supplementary ProvisionsArticle 47 Provisions governing non-profitable contraceptive devices shall be formulated separately by the drug regulatory authority in conjunction with other relevant authorities under the State Council.Article 48 These Regulations shall come into force from April 1, 2000.。
医疗器械临床试验常用词汇英文
医疗器械临床试验常用词汇英文Alright, here are some commonly used vocabulary terms related to medical device clinical trials in a conversational and informal English style:The "participant" is the key player in a clinical trial. They're the volunteers who test the medical device to see if it works as expected.We call the process of testing a medical device on humans "clinical trials." It's essential for ensuring the safety and effectiveness of new treatments.The "investigational device" is the medical devicethat's being tested. It could be a new surgical tool, a diagnostic machine, or any other kind of medical equipment.The "protocol" is like a blueprint for the clinical trial. It details everything from the inclusion criteriafor participants to the specific procedures and datacollection methods."Adverse events" are unexpected health issues that occur during a clinical trial. They're carefully monitored and recorded to ensure the safety of participants.The "principal investigator" is the lead researcher in charge of the clinical trial. They're responsible for overseeing the entire process and ensuring it's conducted ethically and scientifically."Informed consent" is a crucial part of any clinical trial. It's when participants are given all the information about the trial and decide if they want to take part or not.The "control group" is a set of participants in a clinical trial who don't receive the investigational device. They help researchers compare the results and determine if the device is actually working.。
海关对进口医疗器械的检验监管与溯源
海关对进口医疗器械的检验监管与溯源作者：徐胜杨诗晨刘晓东来源：《进出口经理人》2021年第05期近年来，中国（上海）自由贸易试验区（以下简称“上海自贸区”）医疗器械进口持续增长，法定检验进口医疗器械占全国近1/4的业务份额。
医疗器械具有技术发展快、检验要求高、进口量大、贸易方式多样等特点。
在此，我们通过对上海自贸区进口医疗器械检验监管状况的深入研究，探索建立一套规范化的海关检验监管方式，目的是提高海关监管水平和检验质量，降低海关监管风险，在有效把关的同时更好地服务于贸易转型，使自贸试验区成为“推动贸易转型升级，创新监管服务模式”的示范区。
海关对进口医疗器械检验监管，是依据相关法律法规和标准要求或贸易合同，实施品质、安全、数量等项目检验，在进行合格评定后出具相应的检验证单，进口企业以此为凭证在口岸海关办理进口通关手续。
当前，海关对进口医疗器械采用“批次监管-符合性评估”模式。
批次监管，即海关根据企业报关申请，对每批进口医疗器械进行现场检验;符合性评估构成要素为“符合性声明+评估+抽样+检验+检查+监督管理”。
具体检验方式为：（1）派员对进口医疗器械实施开箱检验，并抽取样品送有关实验室进行安全性能检测。
（2）派员对进口医疗器械实施开箱检验，并对设备的后续安装、调试、验收实施现场监督管理。
（3）派员对进口医疗器械实施开箱检验，并对有关单位的验收报告进行审核，必要时可抽查部分项目。
现行的海关监管模式尽管行之有效，但存在如下问题：（1）检验范围不完整。
法检目录（已包含于新版HS编码表中）只包含了一部分中高度风险的医疗器械，而根据《医疗器械监督管理条例》的规定，所有医疗器械都属于法定检验产品。
法检目录有漏洞，可能出现没有备案/注册的医疗器械进入中国市场的情况，存在安全隐患。
（2）缺少产品溯源手段。
目前的批次监管模式缺少产品溯源手段。
一旦进口医疗器械出现问题，无法对问题产品进行有效的追踪溯源，不利于不良事件的处理与医疗器械的召回。
商品检验相关英语词汇
商品检验相关英语词汇商品检验 Commodity InspectionShall we take up the question of inspection today?今天咱们讨论商品检验问题吧。
The inspection of commodity is no easy job.商检工作不是那么简单。
Mr. Black is talking with the Chinese importer about inspecting the goods.布莱克先生与中方进口商就商品检验问题进行洽谈。
As an integral part of the contract, the inspection of goods has its special importance.作为合同里的一个组成部分，商品检验具有特殊的`重要性。
We should inspect this batch of porcelainware to see if there is any breakage.我们要检查一下这批瓷器是否有破损的。
The exporters have the right to inspect the export goods before delivery to the shipping line.出口商在向船运公司托运前有权检验商品。
The inspection should be completed within a month after the arrival of the goods.商品检验工作在到货后一个月内完成。
How should we define the inspection rights?商检的权力怎样加以明确呢？I'm worried that there might be some disputes over the results of inspection.我担心对商检的结果会发生争议。
LCLS Commissioning Schedule and MilestonesLCLS试车计划与里程碑
Start XTOD commissioning
Start Undulator commissioning
UV Beam To cathode
Start LTU commissioning
Start of Operations (X-Rays to Far Hall)
F2Y0200203
20F0Y32004
2F0Y024005
2F0Y025006
Project Engineering Design
Long-Lead Procurement
Construction
2F00Y62007
FY2008
FY2009
Operation
9/22/04
CD-3a
CD-3b
{ Beneficial Occupancies
UH
CLOC BTH, FH
NH DUMP
J. Welch, LCLS Commissioning Worskhop, SLAC
CD-4
FY2010
9/22/04
J. Welch, LCLS Commissioning Worskhop, SLAC
12/06 7/07
UV Beam to Cathode First Beam on Linac Axis
Linac-1
Linac-2 Linac-3
21-1b 21-1d
DL-1
X
21-3b 24-6d
25-1a 30-8c
BC-1
BC-2
4/08
Undulator DL-2
X Ray Far Hall Diag.
7/07
BSY Tune up
Dump Dump
临床试验中所有涉及到得英文翻译(14页)
临床试验中所有涉及到的英文翻译（第1页）1. 临床试验（Clinical Trial）2. 研究参与者（Research Participant）3. 研究方案（Protocol）4. 伦理审查委员会（Institutional Review Board, IRB）5. 知情同意书（Informed Consent Form）6. 试验药物（Investigational Product）7. 对照组（Control Group）8. 实验组（Experimental Group）9. 随机化（Randomization）10. 双盲试验（Doubleblind Trial）11. 病例报告表（Case Report Form, CRF）12. 不良事件（Adverse Event）13. 严重不良事件（Serious Adverse Event）14. 数据监控委员会（Data Monitoring Committee, DMC）15. 统计分析计划（Statistical Analysis Plan, SAP）16. 研究终点（Study Endpoint）17. 临床终点（Clinical Endpoint）18. 效力（Efficacy）19. 安全性（Safety）20. 药物代谢动力学（Pharmacokinetics）21. 药物效应动力学（Pharmacodynamics）22. 生物利用度（Bioavailability）23. 生物等效性（Bioequivalence）24. 药物相互作用（Drug Interaction）临床试验中所有涉及到的英文翻译（第2页）25. 研究目标（Study Objective）26. 研究假设（Research Hypothesis）27. 入组标准（Inclusion Criteria）28. 排除标准（Exclusion Criteria）29. 受试者筛选（Subject Screening）30. 基线评估（Baseline Assessment）31. 随访（Followup Visit）32. 疗程（Treatment Regimen）33. 药物剂量（Drug Dosage）34. 给药途径（Route of Administration）35. 药物耐受性（Drug Tolerance）36. 药物依赖性（Drug Dependence）37. 药物副作用（Side Effect）38. 药物毒性（Toxicity）39. 最大耐受剂量（Maximum Tolerated Dose）40. 疗效评估（Efficacy Evaluation）41. 安全性评估（Safety Assessment）42. 生命体征（Vital Signs）43. 实验室检查（Laboratory Tests）44. 影像学检查（Imaging Studies）45. 病历记录（Medical Records）46. 病历报告（Medical Report）47. 病历审查（Medical Review）48. 病历编码（Medical Coding）49. 病历数据库（Medical Database）临床试验中所有涉及到的英文翻译（第3页）50. 研究协调员（Study Coordinator）51. 主要研究者（Principal Investigator）52. 研究团队（Research Team）53. 监查员（Monitor）54. 申办者（Sponsor）55. 研究资助（Research Funding）56. 研究预算（Research Budget）57. 研究合同（Research Contract）58. 知识产权（Intellectual Property）59. 专利保护（Patent Protection）60. 研究注册（Study Registration）61. 临床试验注册（Clinical Trials Registration）62. 公开透明（Transparency）63. 研究结果发表（Publication of Results）64. 数据共享（Data Sharing）65. 隐私保护（Privacy Protection）66. 受试者隐私（Subject Privacy）67. 保密协议（Confidentiality Agreement）68. 信息安全（Information Security）69. 数据保护（Data Protection）70. 研究合规（Research Compliance）71. 法律法规（Regulatory Requirements）72. 质量保证（Quality Assurance）73. 质量控制（Quality Control）74. 标准操作程序（Standard Operating Procedures, SOPs）。
进口美国医疗器械所需文件清单和要求（英文版）
No.
Name of document
And please prepare the files according to the requirements
Remark
1 Manufacturer’s License
Notarization is necessary.
Quality Management System 2
(ISO 13485)
Notarization iarization is necessary.
5 IEC 60601-1 Test Report
6 certificate(LQC)
the name and address of Laboratory is the same as the one written in your IEC test report.
The list of inspection items of the laboratory is also included.
9 Declaration of conformity 10 All kinds of statements
Please sign and stamp on . Total 6 pages. Please see annex 3 “All kinds of statements”.Please sign and stamp on each of them.
7 Truth and Accuracy Statement
Notarization is necessary. Please see annex 2” Truth and Accuracy Statement.”
常用药监管英语与缩略语
常用药品监管英语与缩略语——浙江省药品监督管理局政策法规处一、监管英语1.《中华人民共和国药品管理法》Drug Control Law of the People's Republic of China2.药品生产企业管理control over drug manufacturers3.药品经营企业管理control over drug distributors4.医疗机构的药剂管理control over medicines in medical institutions5.药品管理control over drugs6.药品包装的管理control over drug packaging7.药品价格和广告的管理control over drug price and advertisement 8.药品监督inspection of drugs9.法律责任legal liabilities10.药品标识labels or marks of the drugs11.假药counterfeit drugs12.劣药inferior drugs13.药品检验机构drug quality control laboratory 14.药品的生产企业drug manufacturers15.经营企业drug distributors16.医疗机构medical institutions17.药品监督管理部门drug regulatory agency18.药品批准证明文件drug approval documents19.行政处分administrative sanctions20.刑事责任criminal liabilities21.药品生产质量管理规范Good Manufacturing Practice for Pharmaceutical Products (GMP)22.药品经营质量管理规范Good Supply Practice for Pharmaceutical Products (GSP)23.药品生产许可证Drug Manufacturing Certificate24.药品经营许可证Drug Supply Certificate25.医疗机构制剂许可证Pharmaceutical Preparation Certificate for Medical Institution26.进口药品注册证书Import Drug License27.临床试验clinical trial28.新药证书New Drug Certificate29.药品批准文号Drug Approval Number30.在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理的单位或者个人，必须遵守《中华人民共和国药品管理法》All institutions or individuals engaged in research, production, distribution, use, and administration and supervision of drugs in the People's Republic of China shall abide by drug control law of the people's republic of China.31.国务院药品监督管理部门主管全国药品监督管理工作。
第三方检验
小结
商品检验定义
商品检验（Commodity Inspection）是指商品的产方、买方或者第三方在一 定条件下，借助于某种手段和方法，按照合同、标准或国内外有关法律、法规、惯 例，对商品的质量、规格、重量、数量、包装、安全及卫生等方面进行检查，并做 出合格与否或通过验收与否的判定或为维护买卖双方合法权益，避免或解决各种风 险损失和责任划分的争议，便于商品交接结算而出具各种有关证书的业务活动。 国际贸易中，由于交易双方身处异地，相距遥远，货物在长期运输过程中难免 会发生残损、短少或者灭失，尤其是在凭单证交接货物的象征性交货条件下，买卖 双方对货物的品质、数量等问题更易产生争议。因此，为了便于查明货损原因，确 认责任归属，以利货物的交接和交易的顺利进行，就需要一个公正的第三者，即商 品检验机构，对货物进行检验或鉴定。由此可见，商品检验是国际货物买卖中不可 缺少的一个重要环节。
这种检验方法不适用于按装运港交货的FOB、CFR、CIF贸易术语。按装运 港交货的贸易术语达成的买卖合同，在规定的检验时间和地点时，采用“出 口国检验、进口国复验”最为适宜，当然，这也会最理想化的检验方法。
小结
上述有关商品检验的介绍都体现了一个共同原则，即除非买卖双方另 有约定，买方在接受货物之前应享有对所购买的货物进行检验的权利。 但需要注意的是，买方对货物的检验权并不是强制性的，它不是买方 接受货物的前提条件。也就是说，如果买方没有利用合理的机会检验 货物，那么他就自动放弃了检验货物的权利。另外，如果合同中的检 验条款规定，以卖方的检验为准，此时，就排除了买方对货物的检验 权。 综上所述，有关商品检验权的规定是直接关系到买卖双方权利与义务 的重要问题，因此，交易双方应在买卖合同中对于商品检验有关的问 题作出明确具体的规定，避免双方在货物质量、重量（数量）等方面 的纠纷，这也是维护长期稳定的供求关系的重要环节。
翻译
欧洲委员会企业暨工业总署F类消费品F3类化妆品及医疗器械医疗器械：指导文件医疗仪器2.12-1 6版2009 12指导方针医疗器械警戒系统本准则属于欧委会所建立有关美容器械方面的整套指导方针之一，其目的是解决欧委会在处理医疗美容器材方面的问题时做指导之用。
本准则不具备法律效应本准则经由各方密切商讨，糅合了各方的意见和建议，精心起草。
（各方：有关当局，欧盟服务委员会，工业部，以及其他团体）暨，该准则代表了医疗美容器材行业各个部门所持有的立场。
医疗美容器材管理准则第六版，含2.12-1 对附件3所做的技术修正（制造商事件报告-报告表）2007年4月所发行的该准这版本-2.12-1保持不变附件3的修正将于2010年三月20日起生效目录1 前言2 简介前言这些基于医疗器械警戒系统的指南是医疗器械指南的一部分，其促进了制造商，指定公告机构（公告机构是一个由欧盟某个成员国的主管当局指定的测试、审核和认证机构，它可从事医疗器械指令的附录中所描述的一种或多种符合性评价程序）和维护公众健康安全的国家主管当局三方达成共识。
指南经过众多相关团体磋商，并且通过初稿测试实施后各方意见被充分采纳的前提下精心起草的，因此它代表了医疗器械行业中各方（主管当局指定机构代办服务制造商其它）的立场。
指令根据管理上的发展有规律的进行更新，建议使用最新的版本，此版本指令：经过慎重考虑后一被转用为欧洲全球医疗器材协会在市场警戒和监管方面国际性规范指令文件。
已被写入欧洲医疗器械库简介根据经验已修改了之前文件中的一些条款此指南不具法律上的约束力，只在特定条件下适用，例如在科技发展下作为可供选择的有可能或者符合合法要求的情况下适用。
但是由于上述相关团体及国家主管当局专家的参与，此指南将会被欧盟各国所采纳，因此此份指南致力于在欧盟内建立统一的能够运行的指令条案和实践做法。
但是只有该指令原文在法律上具有真实性，没写入指南的内容可能与国家法律不符。
2 简介这些指南主要是描述了欧洲系统下对于医疗器械行业中事故及现场安全纠正措施的声明和评价，这就是医疗器械警戒系统。
icc协会冷藏货物条款
icc协会冷藏货物条款1.引言1.1 概述ICC协会冷藏货物条款是国际商会（International Chamber of Commerce，简称ICC）针对冷藏货物运输制定的一系列规定和标准。
随着全球贸易的增长和国际物流的发展，冷藏货物的运输也日益重要。
冷藏货物条款旨在解决冷藏货物运输中可能出现的问题，确保货物在运输过程中保持稳定的温度和质量。
条款中包括了冷藏设备的要求，运输温度的控制方法以及货物的责任分配等方面的内容。
冷藏货物的特点是需要在一定的温度条件下进行运输，这对各个环节的参与者都提出了严格的要求。
货物的发货人需要确保冷链设备的正常运行，并采取适当的措施保证货物在运输过程中的温度稳定。
运输公司和承运人则需要提供符合标准的冷藏设备，确保货物能够在运输过程中达到所要求的温度。
另外，冷藏货物的运输也可能面临一些特殊的情况，比如天气突变、设备故障等。
因此，冷藏货物条款还规定了在这些情况下各方的责任和义务。
例如，如果因天气造成货物温度的波动超过规定范围，责任可能会由一方或多方承担。
总之，ICC协会冷藏货物条款对于确保冷藏货物的质量和安全具有重要意义。
它为冷藏货物的运输提供了一个统一的标准和规范，有助于各个参与者更好地合作，减少货物损失和风险。
在未来的发展中，随着技术的不断创新和国际贸易的进一步扩大，冷藏货物条款也将不断完善，以适应不断变化的需求。
1.2文章结构2. 正文2.1 ICC协会冷藏货物条款要点12.2 ICC协会冷藏货物条款要点21.2 文章结构本文将按照以下结构来讨论ICC协会冷藏货物条款。
首先，引言部分将提供一个概述，描述本文要讨论的内容以及研究的目的。
接下来，正文将重点介绍ICC协会冷藏货物条款的两个要点。
最后，结论部分对文章进行总结，并展望未来研究的方向。
在引言部分，我们将给出一个概述，简要介绍ICC协会冷藏货物条款的背景和重要性。
我们将分析冷藏货物在国际贸易中的地位和必要性，并介绍ICC协会在制定相关条款时所考虑的因素。
LCLS Commissioning Schedule and MilestonesLCLS试车计划与里程碑
UH
CLOC BTH, FH
NH DUMP
J. Welch, LCLS Commissioning Worskhop, SLAC
CD-4
FY2019
9/22/04
J. Welch, LCLS Commissioning Worskhop, SLAC
12/06 7/07
UV Beam to Cathode First Beam on Linac Axis
9/22/04
J. Welch, LCLS Commissioning Worskhop, SLAC
9/22/04
J. Welch, LCLS Commissioning Worskhop, SLAC
Startup Phases
• Phase I - low beam quality
– BBA, radiation reduction, x-ray diagnostics, SR measurements
• Phase II - high beam quality
– low emittance tuning, gain curve measurement, precision x-ray measurements
• Phase III - transition to operation
– Full rep rate, stable operating conditions, full energy range, finalize operational procedures
4/08
Start LTU Commissioning
7/08
Start Undulator Commissioning
海运进口商品残损鉴定办法
海运进口商品残损鉴定办法
【法规类别】进出口商品监督与管理
【发文字号】[89]国检公字第374号
【失效依据】进口商品残损检验鉴定管理办法
【发布部门】国家出入境检验检疫局(原商检局)
【发布日期】1989.07.08
【实施日期】1989.10.01
【时效性】失效
【效力级别】部门规章
海运进口商品残损鉴定办法
（一九八九年七月八日国家进出口商品检验局发布[89]国检公字第374号）
第一章总则
第一条为了做好海运进口商品的残损鉴定工作，维护对外贸易、运输、保险等契约各方的合法权益，根据《中华人民共和国进出口商品检验法》第十一条、第二十五条规定，制定本办法。
第二条商检局凭进口商品的发货人、收货人、保险人、承运人（以下简称对外贸易关系人）的申请和国内外仲裁、司法、检验机构的委托，办理舱口检视、载损鉴定、监视卸载、海损鉴定、验残等海运进口商品残损鉴定工作。
第三条。
西班牙医疗器械法规与生产许可证要求综述
市场规模和增长趋势
西班牙医疗器械市场规模庞大，近年来保持稳定增长。随着人口 老龄化、医疗技术不断进步以及患者对高质量医疗服务的需求增 加，预计未来几年西班牙医疗器械市场将继续保持增长态势。
西班牙政府对医疗领域的投资也在逐年增加，为医疗器械市场提 供了更多的机遇。此外，西班牙还积极参与国际合作，与欧盟和 其他国家共同推动医疗器械行业的发展。
提前了解申请流程和时间节点，合理安排申请计划 ，确保按时提交申请材料。
审核过程中的注意事项
02
01
03
保持与审核机构的良好沟通，及时响应审核过程中的 问题和要求。
重点关注审核机构对产品安全性和有效性的评估，确 保产品质量符合西班牙医疗器械法规要求。
针对审核过程中发现的问题，积极采取改进措施，确 保在规定时间内完成整改。
分类
根据风险等级，医疗器械被分为I类、 IIa类、IIb类和III类，不同类别的医疗 器械有不同的注册和监管要求。
市场准入和注册要求
市场准入
所有在西班牙销售的医疗器械都必须获得市场准入许可，即 CE标志，表明其符合欧盟的安全和健康标准。
注册要求
制造商或其授权代表必须在西班牙药品和医疗器械管理局注 册其医疗器械，并提交必要的技术文档和安全性能评估报告 。对于高风险医疗器械，还需要进行临床试验和额外的审核 。
THANK YOU
感谢聆听
促进医疗器械行业的健康发展
合理的法规框架有助于鼓励医疗器械行业的创新和 发展，同时确保公平竞争和市场透明度。
与国际标准和最佳实践接轨
西班牙的医疗器械法规和生产许可证要求旨在与欧 盟和国际标准保持一致，以便在国际市场上保持竞 争力并促进贸易便利化。
汇报范围
第三批医疗器械唯一标识工作的要求
第三批医疗器械唯一标识工作的要求下载提示：该文档是本店铺精心编制而成的，希望大家下载后，能够帮助大家解决实际问题。
文档下载后可定制修改，请根据实际需要进行调整和使用，谢谢！本店铺为大家提供各种类型的实用资料，如教育随笔、日记赏析、句子摘抄、古诗大全、经典美文、话题作文、工作总结、词语解析、文案摘录、其他资料等等，想了解不同资料格式和写法，敬请关注！Download tips: This document is carefully compiled by this editor. I hope that after you download it, it can help you solve practical problems. The document can be customized and modified after downloading, please adjust and use it according to actual needs, thank you! In addition, this shop provides you with various types of practical materials, such as educational essays, diary appreciation, sentence excerpts, ancient poems, classic articles, topic composition, work summary, word parsing, copy excerpts, other materials and so on, want to know different data formats and writing methods, please pay attention!随着医疗器械监管的不断完善和医疗器械市场的不断拓展，第三批医疗器械唯一标识工作的要求也愈发严格和具体。
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September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
Simplistic View of Digital BPMs
Is the purely digital approach the best way to go? Must always maximize signal to noise for best resolution
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
Diagnostics Roadmap for electrons
Bunch charge
Trajectory resolution
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
Linac stripline BPMs
• Need to replace old BPM electronics • Commercially available processing units look promising • Beam testing of module as soon as funding available • Test new BPM fabrication techniques
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
Stripline versus Cavity BPM Signals
l/4 Stripline
C-band cavity
P. Krejcik pkr@
Context of Diagnostics in Commissioning
Review scope of proposed diagnostics Emphasize that diagnostics themselves need commissioning
Measured signal to noise ratio implies resolution of 7 mm in a 10 mm radius BPM
Identified fixable artifacts in data processing
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
NLC studies of cavity BPMs, S. Smith et al
3 prof. mon.’s (Dyx,y = 60°)
upstream linac
L1 X
L2
DL1
BC1
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
L3
BC2
DL2 undulator
LTU Dump E, DE
BPM modules – trying to attain desired resolution Prof monitor cameras – resolution, controls integration, data rate
Some diagnostics are turnkey systems, others are R&D projects R&D still required for ultrafast diagnostics
So eliminate any cause of attenuation: couplers, hybrids, active devices etc.
This also eliminates drift which causes offsets Other approaches also try to do this: e.g. AM to PM conversion with a hybrid and then digitize Might as well digitize first, eliminate the middle men, and do the conversions digitally Ultimately left with calibrating the drift in the BPM cables, because ADCs are now very stable.
CSR THz power bunch length monitors EO bunch profiling
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
• 2 Transverse RF deflecting Cavities for slice measurements
• 5 Bunch length monitors
RF
* See also P. Emma talk how
gun
optics is optimized for diagnostics
Consider if full features (resolution, automation) are needed at beginning of commissioning Implicit sequence of commissioning: e.g. feedbacks after BPMs commissioned; slice parameters need prof. monitors and TCAVs
i-tech.si
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
Analysis of Test Signals in the “Libera” module – S. Smith
P. Krejcik pkr@
Accelerator System Diagnostics*
• 180 BPMs at quadrupoles and in each bend system
• 8 Energy (BPM) E, energy spread (Prof) sE measurements : • 5 Emittance gex,y measurements (Profs, Wire Scanners) :
LCLS Diagnostics and Commissioning Workshop
Injector, Linac and Undulator Diagnostics and Beam Position Monitors
P. Krejcik
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
Beam Position Monitoring requirements
September 22-23, 2004 LCLS Diagnostics and Commissioning Workshop
P. Krejcik pkr@
P
f 700 MHz
RF in l
500 MHz BP filter
~5 GHz Mixer
IF
Dipole mode coupler
LO sync’ed to RF
ADC x4
Digital Control processing system
119 MHz Clock
24th harmonic
• noise (resolution) minimized by removing analog devices in front of ADC that cause attenuation • drift minimized by removing active devices in front of ADC
Beam Position Monitors
Stripline BPMs in the injector and linac (existing) and in the LTU
Differencing large numbers Mechanical precision
Fabrication by printing electrodes on ceramic tubes
P. Krejcik pkr@
Cavity beam position monitors for the undulator and LTU
R&D at SLAC – S. Smith
Coordinate measuring machine verification of cavity interior
•Position •Angle •Energy
Noninvasive
Beam size
F
resolution
E
•Emittaห้องสมุดไป่ตู้ce
E
•Energy spread
• Setup •Tuning
D
Slice parameters
B
resolution
A
• Emittance
C
K
Bunch length & DT