A clinical trial of a medical device can begin how many days after notification is sent to the Competent Authority?

A clinical trial of a medical device can begin 60 days after the notification is sent to the Competent Authority. This timeline is established by regulatory guidelines to ensure that the Competent Authority has sufficient time to review the submission and address any potential concerns or questions regarding the trial's design, safety, and compliance with regulations.

The 60-day period allows the regulatory body to evaluate whether the trial can proceed based on the information provided. If the Competent Authority does not respond within this timeframe, the trial may typically commence, contingent upon obtaining any necessary ethical approvals. This regulatory framework is in place to safeguard the rights and safety of trial participants and to ensure that the trial is conducted in accordance with established ethical standards.

Other options suggest shorter times or conditions that do not align with the regulatory requirements. Therefore, understanding the significance of the 60-day period is crucial for compliance in regulatory affairs related to clinical trials for medical devices.