Regulation of medical devices A step-by-step guide

The document provides a comprehensive guide on the regulation of medical devices. It emphasizes the primary purpose of implementing regulatory systems for these devices: to protect public health and ensure their safety and performance. The guide notes that while all countries regulate medicines, many delay introducing similar controls for medical devices. The public expects national regulatory authorities to prevent the circulation of unsafe medical devices in the market. The guide also highlights the complexity of regulating medical devices due to the vast variety available, from simple items like bandages to complex equipment like MRI scanners. The risks associated with each device type differ, and regulatory requirements should increase in line with the device's risk. The document advocates for regulations based on internationally harmonized practices, drawing from countries with established medical device legislation. This approach ensures public health benefits, allows for the acceptance of audit results from other regulatory authorities, and reduces the burden on the regulated industry. The guide also touches upon the concept of reliance, where a national regulatory authority can depend on regulatory evaluations from other jurisdictions, provided it's stated by law. This approach can be cost-effective and time-saving.