2015年医疗器械临床评价技术指导原则(英文版).doc

Annex Technical Guidelines for Clinical Appraisal of Medical Devices Ⅰ Drafting objective Clinical appraisal of medical devices is the process implemented by registration applicant to identify whether the product fulfills usage requirements and application scope according to information concerning clinical documents, clinical experiences data, clinical trials and so on. This guidelines is intended to provide technical guide for registration applicant to carry out clinical appraisal as well as for the food and drug administration authorities to review clinical appraisal documents . Ⅱ Laws and regulations basis (Ⅰ) “Medical devices management regulations”No. 650 decree of the state council; (Ⅱ) “Medical devices registration management specifications” No. 4 decree of the state council; (Ⅲ) Relevant specifications for clinical trial quality management of medical devices. Ⅲ Application scope This guidelines is applicable to clinical appraisal of class Ⅱ and class Ⅲ medical devices when they are applied for registration. It is not applicable to clinical appraisal of in vitro diagnostic (IVD) reagents administrated as medical devices. If there is clinical appraisal technical guidelines for specific product, the corresponding clinical appraisal should follow relevant requirements of it. Ⅳ Basic principle Clinical appraisal should be comprehensive as well as objective and corresponding data should be collected by various means such as clinical trials and so on. Clinical performance and safety data collected in clinical appraisal process should be included in analysis no matter it is positive or negative. Clinical appraisal depth and scope as well as data type and data quantity required should be compatible with design feature, key technology, application scope and risk level of the product while they should be also compatible with level and degree of non-clinical research. Clinical appraisal should confirm clinical application information concerning application sco