监查员应具备相关专业背景，如临床医学、药学、生物医学工程或统计学等，并接受必要培训。他们需熟悉相关法规和规范，了解试验用医疗器械的非临床信息、同类产品临床信息，以及临床试验方案及其相关文件。同时，监查员应遵循申办者制定的试验用医疗器械临床试验监查标准操作规程，确保临床试验按方案实施。

Clinical research associates (CRAs) should possess relevant professional backgrounds. Further, CRAs must adhere to the sponsor's standard operating procedures for monitoring clinical trials of investigational medical devices, ensuring trials are conducted according to protocol. High-quality monitoring guarantees compliance with Good Clinical Practice (GCP) requirements.

• Verify that the clinical trial institution meets GCP requirements and has suitable working conditions.
• Oversee the clinical trial institution and investigators' adherence to relevant regulations, standards, and the trial protocol.
• Ensure proper execution of informed consent, screening, enrollment, and follow-up processes for each subject, addressing any issues promptly.
• Confirm the completeness and accuracy of original records, verify consistency between case report forms and original records, and ensure all error corrections are standardized.
• Ensure documentation of all adverse events, complications, and device defects, with timely reporting and recording of serious adverse events and potentially serious device defects.
• Verify maintenance and calibration records for trial-related equipment, and confirm proper documentation.
• Submit a comprehensive written report to the sponsor after each monitoring visit and corrective measures for any errors or omissions.

医疗器械临床评价是注册申请人通过临床文献资料、临床经验数据、临床试验等信息，确认产品是否满足使用要求或适用范围的过程。临床评价应全面、客观，通过多种手段收集数据，包括临床性能和安全性的有利及不利数据。评价的深度、广度、数据类型和数量应与产品的设计特征、关键技术、适用范围和风险程度相适应，并与非临床研究的水平相匹配。

Medical device clinical evaluation assesses product suitability using literature, experience, and trial data. This process impartially gathers performance and safety information, both favorable and unfavorable. The evaluation's depth should correspond to the product's design, technology, use, and risk level, in line with non-clinical research.

• Determine if the product for registration is in the clinical trial exemption catalog, and assess whether differences from exempt products affect safety and efficacy.
• For catalog products, the registration applicant must submit comparison materials between the product for registration and the catalog contents, as well as a comparative explanation with medical devices already approved for domestic registration in the catalog, to prove the equivalence of the product for registration with those described in the catalog.
• If analyzing and evaluating through clinical trials or clinical use data of similar medical devices, first compare the product for registration with one or more similar medical devices to demonstrate their basic equivalence.
• If the product requires clinical trial verification, a clinical trial report should be submitted.
• Clinical data can come from publicly published scientific literature and legally obtained corresponding data from within and outside China. The scope of data collection includes, but is not limited to, completed clinical research data, adverse event data, and corrective measure data related to clinical risks.