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产品技术资料 Product Technical Materials
检验中心 Testing Center
注册检验 Registration Test
注册单元 Registered Unit
预评价意见 Pre-evaluation Opinions
同品种医疗器械 Predicate Medical Device
临床试验机构 Clinical Trial Institutes
伦理委员会 Ethics Committee
多中心临床试验 Multi-center Clinical Trials
形式审查 Formal Examination
认证证书 Certificate Authority, CA
受理通知单 Notice of Acceptance
缴费通知书 Bill of Payment
补正资料通知书 Deficiency Letter
不予受理通知书 Notice of Rejection
发补要求 Requirement of Supplementary
发补后咨询 Consultation after Supplementary
现场咨询 On-site Consultation
网上咨询 Online Consultation
补正资料预审查 Pre-evaluate for Supplementary Documents
专家咨询会 Expert Consultation Meeting
许可事项变更 Changes of Permission Items
登记事项变更 Changes of Registry Items
说明书更改告知 Notification on Instruction for Use Changes
地区性管理信息 Regional Administrative
申报资料目录 Submission Table of Contents
术语缩写词列表 List of Terms/Acronyms
器械列表 Listing of Device(s)
符合性陈述认证声明 Statements/Certifications/Declarations of Conformity
器械描述 Device Description
适用范围和或预期用途及禁忌症 Indications for Use and/or Intended Use and Contraindications
全球上市历程 Global Market History
安全有效基本要求(EP)清单 Essential Principles (EP) Checklist
非临床研究资料 Non-Clinical Evidence
非临床研究 Non-clinical Studies
非临床研究文献 Non-clinical Bibliography
货架寿命和包装验证 Expiration Period and Package Validation
临床证据综述 Overall Clinical Evidence Summary
伦理委员会批准的相关文件 IRB Approved Informed Consent Forms
监管信息 Regulatory information
代理人 Agent
注册代理人 Registered agent
境内申请人 Domestic manufacturing enterprises
境外申请人 Overseas manufacturing enterprises
当地省局 local Provincial Bureau
医疗器械技术审评中心咨询登记表 Registration Form for Consultation at CMDE
医疗器械标准管理研究所 Center for Standardized Supervision
医疗器械检验资质 Medical Device Test Qualification
检测中心承检目录库 Test Directory of Test Center
需进行临床试验审批的第三类医疗器械目录 Catalogue of Class III Medical Devices Requiring Approval of Clinical Trials
同品种比对 Comparison with Predicate Medical Device 
基本等同 Substantial Equivalent (SE)
申报产品 Subject Product
临床试验方案 Clinical trial protocol
小样本可行性研究 Small sample feasibility study
伦理委员会意见 Ethics Committee opinions
安全性评价方法 Safety evaluation method
有效性评价方法 Effectiveness evaluation method
专家咨询会议 Expert consultation meeting
医疗器械监督管理司 Department of Medical Device Regulation
中国食品药品检定研究院 National Institutes for Food and Drug Control
国家药典委员会 Chinese Pharmacopoeia Commission
中国食品药品国际交流中心 China Center for Food and Drug International Exchange
中华人民共和国药典 Pharmacopoeia of the People’s Republic of China
中华人民共和国标准化法 Standardization Law of the People’s Republic of China
医疗器械质量抽查检验管理办法 the Administrative Measures for Sampling Inspection of Medical Device Quality
国家药品监督管理局重点实验室管理办法 the Administrative Measures for Key Laboratories of NMPA
医疗器械产品出口销售证明 Export and selling license for medical devices
医疗器械生产许可证 Manufacturing Certificate for Medical Device
医疗器械生产备案凭证 Manufacture Filing Certificate of Medical Devices
内部核查 Internal verification
网络核验 Online verification
医疗器械注册申报资料要求和批准证明文件格式的公告 Announcement on the Requirements for Registration Application Dossiers of Medical Devices and the Format of Approval Documents
体外诊断试剂注册申报资料要求和批准证明文件格式的公告 Announcement on the Requirements for Registration Application Dossiers of In Vitro Diagnostic Reagents and the Format of Approval Documents
医疗器械强制性行业标准 Mandatory Industry Standards of Medical Devices
强制性行业标准体系 Mandatory industry standards system
医疗器械定期风险评价报告 Periodic Risk Evaluation Reports of Medical Devices
医疗器械生产质量管理规范独立软件现场检查指导原则 Guidance for On-Site Inspection of Independent Software Appended in Good Manufacturing Practice for Medical Devices
高值医用耗材 High-value medical consumables
集中采购 Centralized procurement
无菌和植入性医疗器械监督检查 Supervision and Inspection of Sterile and Implantable Medical Devices
医疗器械注册人 Medical Device Registrants
国家医疗器械不良事件监测信息系统 the National Medical Device Adverse Event Monitoring Information System
医疗器械不良事件信息通报 Medical Device Adverse Event Information Notification
医疗器械警戒快讯 Medical Device Pharmacovigilance Expresses
可疑医疗器械不良事件报告 Suspected medical device adverse events
医疗器械拓展性临床试验管理规定 Regulations for Administration of Medical Device Extended Clinical Trials
医疗器械唯一标识数据库 Medical device unique identification database
医疗器械通用名称命名 Nomenclature for Common Names of Medical Devices
国家药品监督管理局 National Medical Products Administration, NMPA
国家卫生健康委 National Health Commission NHC
医疗器械标准管理中心 Management Center for Medical Device Standards
医疗器械技术审评中心 Center for Medical Device Evaluation, CMDE
医疗器械监督管理条例 Regulations for the Supervision and Administration of Medical Devices
医疗器械注册管理办法 Provisions for Medical Device Registration
体外诊断试剂注册管理办法 Provisions for In-Vitro Diagnostic Reagent Registration
医疗器械说明书和标签管理规定 Provisions for Instructions and Labels of Medical Devices
医疗器械标准管理办法 Provisions for Medical Device Standards
医疗器械分类规则 Rules for Classification of Medical Devices
医疗器械临床试验质量管理规范 Good Clinical Practice for Medical Devices
医疗器械生产质量管理规范 Medical Device GMP
医疗器械不良事件监测和再评价管理办法 Provisions for Medical Device Adverse Event Monitoring and Re-evaluation
医疗器械质量抽查检验管理办法 Administrative Measures for Sampling Inspection of Medical Device Quality
医疗器械注册人制度 Medical Device Registrant System
创新医疗器械特别审查程序 Special Review Procedures of Innovative Medical Devices
医疗器械附条件批准上市 Conditional Approval for Marketing of Medical Devices
医疗器械产品注册项目立卷审查 Filing Review of Registration Items of Medical Device
医疗器械注册电子申报信息化系统 electronic Regulated Product Submission (eRPS) system
医疗器械注册电子申报 Electronic Application of Medical Device Registration
首次注册 Initial registrations
延续注册 Registration renewals
变更注册 Registration alterations
医疗器械检验检测机构 Medical Device Inspection and Testing Organizations
临床试验审评申请 Application for Clinical Trial Examination and Approval
免于进行临床试验医疗器械目录 Catalogues of Medical Devices Exempted from Clinical Trials
医疗器械注册质量管理体系核查 Verification of Medical Device Registration Quality Management System
生产现场检查 Production Site Inspections
医疗器械安全和性能基本原理 Fundamental Principles for Medical Device Safety and Performance
申报资料 Application Dossiers
注册审评审批 Registration Review and Approval
国家医疗器械不良事件监测年度报告 Annual Report for National Medical Device Adverse Event Monitoring
国产器械 Domestic device
进口器械 Imported device
外源因子 Adventitious agents
阳性对照试验 Active controlled trials
申请人 Applicant
简要总结 Brief summary
获益与风险结论 Benefits and risks conclusions
生物药剂学研究 Biopharmaceutic studies
生物利用度 Bioavailability
生物等效性 Bioequivalence
临床综述 Clinical overview
临床总结 Clinical summary
临床研究报告 Clinical study reports
临床有效性 Clinical efficacy
临床安全性 Clinical safety
临床药理学 Clinical Pharmacology
控制策略 Control strategy
药典各论 Compendial monographs
关键步骤 Critical steps
药典 Compendial
对照临床试验 Controlled clinical trials
物料控制 Control of materials
通用技术文档 Common technical document
浓度 Concentration
包装系统 Container closure system
制剂 Drug product
双盲、阳性对照试验 Double blind,active controlled trial
原料药/原液 Drug substance
剂型 Dosage form
双盲、安慰剂对照试验 Double blind, placebo-controlled trial
设备 Equipment
辅料 Excipient
有效性 Efficacy
设施 Facility
结果 Findings
指南 Guidance
粒度文件 Granularity document
基本信息 General information
通用术语表 General glossary of terms
一般原则 General principles