The Perspectives and Expectations on Medical Device Application from Taiwan HighTech Industry

1
The Perspectives and Expectations on Medical
Device Application from Taiwan High-Tech Industry
Ophthalmic Medical Device

• Anita Chen

2
Medical Device Directives

• 90/385/EEC Active implantable
• 93/42/EEC General
• 98/79/EECIn vitro diagnostic

3
Quality System

• ISO 13485
• US Quality System Regulation
• CANADA 13485
• JGMP
• GMP

4
Examples of Harmonized European Standards for
Medical Devices

• EN 60601 Medical Electrical Equipment
• EN ISO 10993 Biological evaluation of medical
  devices
• EN ISO 13485 Quality management system
  Requirements for regulatory purposes
• EN ISO 14155 -1/2 Clinical investigation of
  medical devices for human subjects
• EN ISO 14971 Medical devices Application of
  risk management to medical devices

5
Essential Requirements

• Electrical Safety
• Electromagnetic Compatibility
• Software Safety
• Biocompatibility, Toxicological safety
• Sterilization
• Compatibility with pharmaceuticals and chemicals
• Compatibility with medical procedures(NMR..)

6
Essential Requirements

• Measuring function
• Radiation protection, ionizing and no-ionizing
• Mechanical safety and performance, Noise,
  dimensions
• Release / dosage of substance ( ex.
  Pharmaceuticals)
• Release / dosage of energy
• Thermal safety

7
Essential Requirements

• Traceability, Optical properties (IOL, Laser)
• Compatibility with accessories
• Risk management
• Labeling , instructions for use, symbols

8

• Satisfy Customer Focus
• Meet Regulatory Obligation

Thank you