The initial importer of a medical device MUST:

The responsibility of the initial importer of a medical device includes various critical regulatory obligations, one of the most significant being the requirement to report incidents where a device may have caused or contributed to a death or serious injury. This requirement is rooted in the overarching aim of ensuring patient safety and maintaining the integrity of the medical device regulatory framework.

When an initial importer identifies that a device has been associated with a serious injury or death, they are obligated to act promptly to report these incidents to the appropriate regulatory authority, such as the FDA in the United States. This process is vital for monitoring the safety and effectiveness of medical devices in the market and allows regulatory bodies to take necessary actions, whether it be further investigation, product recalls, or updates to labeling and usage instructions. The timely reporting of such serious incidents plays a crucial role in the vigilance system that protects public health.

While maintaining quality assurance files, sharing responsibility for submissions with other distributors, and reporting device malfunctions are also important aspects of regulatory compliance, they do not carry the same immediate urgency in relation to life-threatening situations as the reporting of serious incidents. Therefore, option A accurately captures a fundamental regulatory duty of an initial importer regarding patient safety and incident reporting.