医疗器械GCP(Good Clinical Practice for MedicalDevices)的目的是确保医疗器械临床试验过程的科学性、规范性和伦理性,从而保护受试者的权益和安全,确保试验结果的准确性和可靠性。具体来说,医疗器械GCP的目的包括以下几个方面: 保护受试者权益和安全:医疗器械GCP的首要目的是保护参与临床试验的受试者的权益和安全。这...
1. 与质量管理体系的衔接 2. 增加了临床风险管理的概念 3. 临床试验的设计 列出了许多参考文献，其中就有FDA的指南文件：《Design considerations for pivotal clinical investigations for medical devices-guidance for industry,clinical investigators,institutional review boards and Food and Drug Administration》...
《Design considerations for pivotal clinical investigations for medical devices-guidance for industry,clinical investigators,institutional review boards and Food and Drug Administration》 因此,可以看出FDA的临床试验指南是全球共享的,国际临床试验设计也可以依照该FDA指南操作。 4. 样本量 ISO 14155:2020版文件中的...
The new MDR requires small to midsize medical device companies to take over the ‘Sponsor responsibilities’ for their clinical trials. Further information Regulatory Affairs Regulatory Affairs The regulatory start-up process is critical for clinical trials. Delays can impact study timelines. We ...
《Design considerations for pivotal clinical investigations for medical devices-guidance for industry,...
Good Clinical Practice for Medical Devices(Decree No.28) Matters related to the implementation of the good management practice for clinical trials of medical devices(No.21-2022) China Clinical Trials GCP –Key Changes Manufacturers, sponsors and others running or planning clinical trials should be aw...
Essential threshold conditions for conducting clinical research on medical devices 确保合规性 GCP证书确保医疗器械研究遵循国际/国内标准,符合法规要求。 提升质量 促进临床试验的科学性、伦理性,确保数据可靠性和准确性。 推动市场准入 有助于获得监管机构认可,提高医疗器械上市的成功机会。
日本厚生劳动省(Ministry of Health Labor and Welfare, MHLW), 在2004年4月1日成立了医药品和医疗器械管理局(Pharmaceuticals and Medical Devices Agency, PMDA), 协助医药品及医疗器械的上市注册工作, 也负责GCP的检查与稽查工作。以下简介PMDA的GCP检...
Essential threshold conditions for conducting clinical research on medical devices 确保合规性 GCP证书确保医疗器械研究遵循国际/国内标准,符合法规要求。 提升质量 促进临床试验的科学性、伦理性,确保数据可靠性和准确性。 推动市场准入 有助于获得监管机构认可,提高医疗器械上市的成功机会。
The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware. 4.3.2在受试者参加一个试验期间或以后,研究者/研究机构应当保证为受试者的任何不良反应,包括与试验有关的临床上有意义的实验室测定值提供合宜的医疗保健。