Clinical Institution Selection

凭借我们团队在合规注册领域的丰富经验，能够为申办方提供专业的指导，协助筛选和评估最适合的临床试验机构。

We offer strategic guidance in selecting appropriate institutes for initiating clinical trials of medical devices in China, leveraging our extensive network and industry expertise to optimize trial outcomes and regulatory compliance.

Key points should be considered:

• Consider the level and geographical location of clinical trial institutions based on product characteristics.
• Choose medical device clinical trial institutions with certified qualifications to ensure their facilities and conditions can safely and effectively conduct clinical trials.
• Investigators should possess the appropriate professional expertise, qualifications, and capabilities, and receive necessary training.
• Investigators responsible for clinical trials should meet the following conditions: hold a senior professional technical title (such as associate chief physician, associate professor, associate researcher, etc.) or above in the relevant field at the clinical trial institution; possess the professional knowledge and experience required for the investigational medical device, and receive relevant training when necessary; be familiar with the sponsor's requirements and the clinical trial-related materials and literature provided; be able to coordinate and manage trial personnel and equipment, and have the ability to handle potential adverse events and other related issues that may arise with the investigational medical device.
• Be familiar with relevant national laws, regulations, and this standard.