What are the requirements for conducting Class III medical devices in device clinical trials

Site requirements, personnel requirements, product requirements, other relevant laws and regulations requirements.

According to the official website of the China Healthcare Commission, the requirements for Class III medical device certificates are: site requirements, which must be of an office nature, with an area of at least 45 square meters; personnel requirements, which require the filing of three relevant personnel (the person in charge of the company, the person in charge of quality, and the quality inspector) and the holding of certificates; and product requirements, which require the information of the products that are in line with the scope of business, and the issuance of certificates; and other relevant legal and regulatory requirements. Product requirements: must have product information in line with the scope of business, and issue certificates, other relevant laws and regulations. In accordance with relevant laws and regulations without obtaining a license to practice medical institutions unauthorized practice.