Regulations and Standards relevant to the production of dialysis catheters:

United States

1. FDA Regulations:
   • 21 CFR Part 820: Quality System Regulation (QSR)
   • 21 CFR Part 807: Establishment Registration and Device Listing
   • 21 CFR Part 801: Labeling Requirements
2. ISO Standards:
   • ISO 13485: Quality Management Systems for Medical Devices
   • ISO 14971: Application of Risk Management to Medical Devices

European Union

1. Medical Device Regulation (MDR) 2017/745
2. CE Marking: Required for market entry in the EU

International Standards

1. ISO Standards:
   • ISO 10555-1 to 5: Sterile, Single-Use Intravascular Catheters
   • ISO 10993: Biological Evaluation of Medical Devices
2. Good Manufacturing Practices (GMP): Global standards for production quality

Specific Considerations for Dialysis Catheters

1. Biocompatibility Testing
2. Sterilization Standards
3. Performance Testing

Post-Market Surveillance

1. Adverse Event Reporting
2. Recalls and Corrective Actions

National Regulations

1. Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
2. Canada: Health Canada Medical Devices Regulations (SOR/98-282)

Dialysis Blood Tube Assembly Line