How Do Clinical Trials Work for Medical Devices in El Salvador?
Medical Device Clinical Trials in El Salvador are important tests for new medical devices. These tests must be done before devices can be used on patients. This article will explain how clinical trials are done for devices in El Salvador.
Regulatory Framework for Medical Device Trials
MINSAL requires medical device companies to obtain authorization before beginning any clinical investigation. A thorough submission must be made providing details on the device, trial protocol, and plans for ensuring patient safety. MINSAL will review the submission and approve devices that meet all regulatory standards. This oversight helps affirm medical device trials are carefully planned and risks to participants are minimized.
Stages of Clinical Investigation
Medical device clinical trials generally proceed through several stages. The first stage, called bench testing, involves testing devices in a laboratory setting to evaluate safety and effectiveness.
If bench testing is successful, trials move to the next stage of animal testing to further explore safety and how the device might impact a living subject.
Following positive animal data, trials can begin first-in-human studies or “Phase I” trials focused on additional safety testing with a small number of human participants.
Further expansion to Phase II and III trials enrolls more participants to gather additional data on safety and how well the device achieves its intended medical purpose.
Larger Phase III trials are needed to statistically confirm device safety and effectiveness for regulatory clearance.
Conclusion
Careful clinical investigation of new medical devices is crucial before making them available to patients who need improved treatment options. Although Medical Device Clinical Trials in El Salvador is a lengthy process, stringent oversight of device trials ultimately benefits both the medical community and public health in El Salvador.
If you have a new medical device and want to test it in El Salvador, contact bioaccess®. We can help you with all parts of doing a clinical trial, from starting paperwork to reviewing results. Call us to discuss helping with your important research.
