Drugdu.com expert's response:

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Conducting medical device clinical trials must meet a series of stringent requirements to ensure the scientific, ethical, and safe conduct of the trials. Based on relevant regulations and norms, the following are the key requirements:

Ethical Committee Approval

Medical device clinical trials must obtain approval from an ethical committee. The ethical committee evaluates the ethical and moral aspects of the trial to ensure that it does not pose unnecessary risks to participants.

Planning and Design

The trial should have a detailed plan and design, including research objectives, methods, recruitment and inclusion criteria, exclusion criteria, etc., to ensure the scientific and reliable conduct of the trial.

Participant Recruitment and Informed Consent

The recruitment process for trial participants must be clearly defined, including the source of participants, recruitment methods, and how to obtain their informed consent. Participants must fully understand the trial content and sign an informed consent form, with their rights and interests being fully protected.

Safety and Monitoring

Effective monitoring and management of participant safety during the trial must be ensured, including the reporting and handling of adverse events.

Data Collection and Analysis

A detailed data collection plan should be developed, and scientific methods should be used to analyze the data to assess the effectiveness and safety of the medical device. Trial data must be properly managed and reported according to standards to ensure its reliability and verifiability.

Funding and Resources

Adequate funding and resources should be ensured to support the smooth conduct of the trial, including researchers, equipment, and trial sites.

Legal and Regulatory Requirements

Compliance with national and regional laws and regulatory requirements must be ensured, including the registration and approval procedures for medical devices.

Trial Institution and Personnel Qualifications

Medical device clinical trials should be conducted in medical device clinical trial institutions that meet the required conditions and have been registered according to regulations. The trial institution should have a corresponding clinical trial management department responsible for the management of medical device clinical trials.
Researchers should possess the professional qualifications and abilities to undertake the clinical trial and have undergone relevant training.

Ethical Committee Review of the Trial Institution

The quality management system of the clinical trial sponsor should submit relevant documents such as the clinical trial protocol, investigator's brochure, and informed consent form text to the ethical committee to ensure that the clinical trial complies with relevant laws and regulations and undergoes review by the ethical committee.

Trial Quality and Risk Management

The sponsor should establish a system that covers medical devices to protect the rights and safety of subjects. Risk assessments should be conducted to ensure that potential risks during the trial are properly managed.

Requirements for Multi-institution Trials

Medical device clinical trials should be conducted in two or more medical device clinical trial institutions. The selected trial institutions should be qualified medical device clinical trial institutions with facilities and conditions that meet the needs for safely and effectively conducting clinical trials.

In summary, conducting medical device clinical trials requires meeting various requirements to ensure their scientific, ethical, and safe conduct. These requirements help protect the rights and interests of participants and provide reliable data support for the safety and effectiveness of medical devices.