Medical Device Regulation

Medical Device Regulation refers to the rules and guidelines set by governments to ensure that medical devices—like pacemakers, insulin pumps, and surgical instruments—are safe and effective for public use. These regulations govern the design, testing, manufacturing, and marketing of these devices to protect patients and healthcare providers. Authorities assess a device’s risk level and may require clinical trials for higher-risk items, ensuring they work as intended before being approved for widespread use. This process helps prevent harmful or ineffective products from reaching the market, ensuring patient safety and boosting trust in medical technology.