For patient safety and regulatory compliance, manufacturers must implement effective medical device tracking systems. In China, regulatory authorities have significantly enhanced oversight, requiring a registration system across production, sales, and usage stages to ensure product traceability and quality tracking.
FDA Medical Device Tracking Requirements
In the United States, the FDA mandates strict tracking requirements under 21 CFR Part 821. These include:
● Devices likely to cause serious health consequences if they fail.
● Devices intended to be implanted for more than one year.
● Life-sustaining or life-supporting devices used outside a device user facility.
Tracking Methods:
● Standard Operating Procedures (SOPs): Develop and maintain SOPs for tracking.
● Quality Assurance Programs: Ensure accuracy and reliability of tracking information.
● Distribution Records: Maintain detailed records of device distribution.
● Patient Information: Track devices to specific patients when necessary, with patient consent.
iDPRT Barcode Label Printers in Medical Device Tracking
iDPRT provides precise medical device labeling solutions for equipment manufacturers. Our barcode printers seamlessly integrate with medical device inventory tracking software, ensuring unique and universal product identification. This enhances device traceability throughout distribution and use.
Our high-performance medical device label printers produce sharp, durable barcode and UDI labels for implants, therapeutic devices, diagnostic equipment, and other tools. This ensures advanced, efficient management and tracking of medical devices, improving data accuracy and allowing easy access to product details like batch numbers and manufacturing dates for quality control and healthcare providers.
For bulk UDI label printing and medical device label printing in the manufacturing industry, we recommend the iDPRT iK4-R600 barcode printer with a verifier. It provides online inspection, eliminates duplicate barcodes, and ensures 100% full inspection, significantly improving the quality of barcode label printing.
With iDPRT, you can be confident in achieving superior efficiency, accuracy, and compliance in medical device labeling. Transform your device management with our advanced labeling solutions today!
