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委员会指令 2005/28/EC 规定了用于人类用途的临床试验良好实践的原则和详细指南 以及此类临床试验的制造或进口授权要求

COMMISSION DIRECTIVE 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of suc

髋关节置换系统 (HRSs) 临床试验设计的标准指南

Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)

含铜宫内避孕器 临床研究的设计、执行、分析和解释指南

Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies

临床试验生物样本伦理管理要求

Bioethical Management Requirements for Clinical Trial Biological Samples

药物临床试验受试者招募管理技术服务规范

Technical Service Specifications for the Recruitment and Management of Drug Clinical Trial Subjects

涉及人的生物医学研究伦理审查规范

Code of Ethics Review for Biomedical Research Involving Humans

基于区块链和对象标识符(OID)的药物临床试验数据应用规范

Specification for the Application of Drug Clinical Trial Data Based on Blockchain and Object Identifier (OID)

眼科植入物 人工晶状体 第7部分：临床研究

Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations

健康信息学 药品识别 用于受监管药品信息的唯一识别和交换的数据元素和结构（草案）

Health Informatics Drug Identification Data elements and structures for the unique identification and exchange of regulated drug information (Draft)

人体适用的医疗美利体育官网首页网址的临床调查 第1部分：一般要求（草案）

Clinical Investigation of Medical Devices Suitable for Humans Part 1: General Requirements (Draft)

人体医疗器械的临床研究. 良好临床实践(ISO 14155-2020); 德文版 EN ISO 14155-2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020

非侵入式血压计. 第2部分: 自动测量类型的临床研究 (ISO 81060-2-2013); 德文版本EN ISO 81060-2-2014

Non-invasive sphygmomanometers - Part 2: Clinical invastigation of automated measurement type (ISO 81060-2:2013); German version EN ISO 81060-2:2014

眼科光学. 隐形眼镜和隐形眼镜护理产品. 临床研究指南

Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations

医用药物. 为实施药物用人体临床试验和上市许可的非临床安全研究指南

Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

进行医疗器械临床试验的指南 第1部分：一般要求

Clinical investigation of medical devices for human subjects. Part 1. General requirements

眼科植入物.眼内透镜.第7部分:临床美利体育登录入口官网

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations

用于人体的医疗器械临床研究. 良好的临床实践

Clinical investigation of medical devices for human subjects - Good clinical practice

医学美利体育官网首页网址对人类临床调查 - 良好的临床实践

Clinical investigation of medical devices for human subjects — Good clinical practice

人体医疗器械的临床研究.良好临床实践

Clinical investigation of medical devices for human subjects — Good clinical practice

临床试验用橡胶避孕套.物理特性的测量

Rubber condoms for clinical trials - Measurement of physical properties

人类受试医疗器械的临床研究 良好临床实践（ISO 14155:2020）

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

儿科系统常见病中药临床试验 设计与评价技术指南 第1部分：厌食

Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for common diseases in the pediatric system Part 1: Anorexia

儿科系列常见病中药临床试验 设计与评价技术指南 第4部分：小儿腹泻

Technical guidelines for the design and evaluation of traditional Chinese medicine clinical trials for pediatric series of common diseases Part 4: Diarrhea in children

祛痘类功效性护肤品临床评价标准

Clinical Test Assessment of anti-Acne Cosmetics

牙膏功效评价 第2部分：防龋

Efficacy evaluation of toothpaste.Part 2:Guidelines for anti-caries efficacy evaluation

牙膏功效评价 第4部分：抗牙本质敏感

Efficacy evaluation of toothpaste.Part 4:Guidelines for efficacy evaluation on dentin hypersensitivity

钛及钛合金牙种植体临床试验指南

Clinical trial guideline for titanium and titanium alloy dental implant

医疗器械临床评价 术语和定义

Medical Device Clinical Evaluation Terms and Definitions

体外诊断试剂临床试验 术语和定义

Terms and definitions for clinical trials of in vitro diagnostic reagents