国际医疗器械监管机构论坛（IMDRF）近期就一份文件草案展开了磋商，其中该文件草案规定了监管机构对合格评定机构（CAB）的认可要求。该文件草案提出了监管机构对医疗器械合格评定机构认可的一般要求和具体要求，以及对医疗器械合格评定机构的结构要求、资源要求、过程要求、管理体系要求和信息要求。另一方面，该文件草案还概述了监管机构撤销合格评定机构认可的相应程序。文件草案在其 “一般要求”部分，还讨论了法律和合同事宜，其中包括：“如果一个法人实体被认定违反了与医疗器械有关的国家法律或法规，或涉及任何欺诈或不正当行为，则该法人实体没有资格成为医疗器械合格评定机构。”整个文件草案中的各项要求都是根据国际产品、过程和服务认证机构标准建立的（即ISO/IEC17065:2012《合格评定 - 产品、过程和服务认证机构要求》）。ISO/IEC17065:2012例外情况是指ISO/IEC 17065:2012中的某些要求不适用于上市前审查合格评定，而对于医疗器械合格评定机构的具体要求是指ISO/IEC17065:2012相关要求之外的要求。该文件草案中的第一部分具体要求涉及ISO 17065:2012中所述的公正性管理、责任和财力、保密性和可公开获取的信息。该文件草案中确定了合格评定机构应确保正在接受审查的上市前申请中所需包含的信息要素，这属于过程要求的一部分。这类要素包括可以证明产品属于医疗器械的相应证据、风险分类情况以及制造商采用的合格评定程序。医疗器械合格评定机构还应确保该上市前申请包含足够的支持性证据，以便证明其符合IMDRF安全性和性能基本原则。去年10月，IMDRF发布了上述基本原则最终文件（即《医疗器械及体外诊断器械安全性和性能基本原则》（IMDRF/GRRP 82 WG/N47FINAL:2018））。IMDRF解释说，该文件草案旨在对其于2016年定稿的《审查员能力、培训、行为要求》文件进行适当补充。上述这两份文件均由IMDRF下设的医疗器械良好评审规范（GRRP）工作组制定，该工作组由美国FDA器械和放射健康中心（CDRH）领导牵头。GRRP工作组计划利用一系列最终文件创建一个项目，暂定名为医疗器械单一审查项目（MedicalDevice Single Review Program），由CDRH中心主任牵头，以便不同监管机构能够完全或部分依赖彼此做出的决定。
IMDRF Drafts Requirements for Recognition of Conformity Assessment Bodies
The International Medical Device Regulators Forum (IMDRF) opened a consultation on a draft document that sets forth requirements for regulatory authorities’ recognition of conformity assessment bodies (CABs).The draft document proposes general and specific requirements as well as structural, resource, procedural, management system and information requirements for a regulatory authorities’ recognition of CABs for medical devices. It also outlines a process for authorities to revoke recognition.General requirements discuss legal and contractual matters. “A legal entity is ineligible to be a medical device CAB if the entity has been found guilty of an offense against national laws or regulations related to medical devices, or relating to any fraudulent or dishonest practices.”Requirements throughout draft document are based on the international standard on certification bodies’ process and services, known as ISO/IEC 17065:201ISO/IEC 17065:2012.Exceptions are those that do not apply to premarket review conformity assessment and the specific requirements are in addition to those in ISO/IEC 17065:2012. The first set of specific requirements in the draft document addresses management of impartiality, liability and financing, confidentiality and publicly available information in accordance with 17065:2012.As part of the process requirements, the draft document identifies elements of information that CABs should make sure are included in premarket applications under review. These include evidence in support of the product's qualification as a medical device, risk classification and the conformity assessment procedures the manufacturer applied. CABs should also ensure that the application contains enough supporting evidence on conformity with IMDRF essential principles of safety and performance. The final document on essential principles was posted last October.IMDRF explains that the draft document is intended to complement its document on competence, training and conduct requirements for regulatory reviewers, which was finalized in 2016. Both documents were developed by the Good Regulatory Review Practices (GRRP) working group (WG), which is chaired by the US Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The GRRP WG plans to use the collection of final documents to create a program, tentatively dubbed the Medical Device Single Review Program, with the CDRH director leading efforts for regulators to rely in whole or inpart on each other’s decisions.The consultation on the new draft document is set to close on 3 October.
来源：RAPS
原文链接：https://www.raps.org/news-and-articles/news-articles/2019/8/imdrf-drafts-requirements-for-recognition-of-confo
整理翻译：奥咨达
