Medical device regulation encompasses the rules and standards set by regulatory authorities to ensure the safety, efficacy, and quality of medical devices. Compliance with these regulations is crucial for manufacturers, importers, and distributors to bring products to market legally and responsibly, protecting both patients and healthcare professionals from potential risks and harm.
These regulations also govern liability issues, holding stakeholders accountable for any adverse events or malfunctions associated with medical devices. Understanding and adhering to regulatory requirements not only mitigate legal risks but also uphold the integrity and trust of the healthcare industry.