Management Provision On The Self-Testing For Medical Device Registration (Final)


为加强医疗器械(含体外诊断试剂)注册管理,规范注册申请人注册 自检工作,确保医疗器械注册审查工作有序开展,根据《医疗器械监 督管理条例》《医疗器械注册与备案管理办法》《体外诊断试剂注册 与备案管理办法》,制定本规定。

In order to strengthen the registration management of medical devices (including in vitro diagnostic reagents), standardize the registration and self-testing of registration applicants, and ensure the orderly conduction of medical device registration review work, in accordance with the “Regulations on the Supervision and Administration of Medical Devices”, “Administrative Measures for the Registration and Filing of Medical Devices” and “Regulations on the Registration and Filing of In Vitro Diagnostic Reagents”, this Management Provision of the Self-Testing for Medical Device Registration is formulated.

一、 自检能力要求
I. Requirements for Self-testing Capability

i. General Requirements

注册时开展自检的,注册申请人应当具备自检能力,并将自检工 作纳入医疗器械质量管理体系,配备与产品检验要求相适应的检验设备设施,具有相应质量检验部门或者专职检验人员,严格检验过程控 制,确保检验结果真实、准确、完整和可追溯,并对自检报告负主体 责任。

For those who carry out self-testing during registration, the registration applicant shall have the capability of self-testing, incorporate the quality management of self-testing into the quality management system of medical devices, provide testing equipment and facilities suitable for product test requirement, have corresponding quality inspection departments or full-time inspection personnel, and strictly control the inspection process to ensure that the test results are true, accurate, complete and traceable, and take the main responsibility for the self-testing report.