医疗器械上市前审评人员能力培养要求国际经验和中国实践

International Experience and Chinese Practice on Competence and Training Requirements for Medical Device Pre-market Reviewers

高素质的审评人才队伍是提升医疗器械审评质量和效率的关键。《审查人员能力、培训和行为要求》指南是国际医疗器械监管机构论坛(International Medical Device Regulators Forum,IMDRF)下设工作组医疗器械良好审查规范(Good Regulatory Review Practice,GRRP)历时一年半,由IMDRF成员国共同起草完成的共识性文件。该指南文件载列了医疗器械监管机构对负责医疗器械上市前审评审批的相关人员所规定的一组通用的能力、培训和行为要求,意在协调各监管机构上市前审评审批质量要求。文章通过介绍GRRP工作组工作目标及《审查人员能力、培训和行为要求》指南文件主旨,结合我国医疗器械审评质量管理、审评人员培养现状,研究思考审评人才管理和能力培养的重点和方向。

A high-quality team of reviewer is the key to improving the quality and efficiency of medical device pre-market reviews.“Competence, Training, and Conduct Requirements for Regulatory Reviewers” is a consensus document that drafted by International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices (GRRP) working group for a year and a half. This guidance document sets out a common set of capabilities, training, and behavioral requirements set by the medical device regulatory authorities for those responsible for pre-marketing review of medical devices, which helps to narrow the differences in the pre-market review process for each regulatory authorities. The purpose of this article is to introduce the main objectives of the GRRP working group’s work, the major requirements from “Competence, Training, and Conduct Requirements for Regulatory Reviewers” document, and analyses the management of talents in China medical device pre-market review.