What are the preclinical studies of experimental medical devices that the sponsor must complete before clinical trials?

Animal experiments, in vitro experiments, pre-clinical observation and research, etc.

1. Animal experiment: The applicant needs to conduct experiments on animal models to evaluate the safety and effectiveness of medical devices used in the experiments. Pharmacokinetics, toxicology and biology of animals have been studied.

2. In vitro experiment: The organizer will also conduct in vitro experiments to evaluate the biocompatibility, material characteristics and effects on cells and tissues of medical devices used in the experiment by using methods such as cell culture and tissue section.

3. Pre-clinical observation and research: Before the clinical trial, the applicant should also conduct pre-clinical observation and research to evaluate the feasibility and potential effect of experimental medical devices.