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

2. Medical Device Directives  90/385/EEC : Active implantable  93/42/EEC: General  98/79/EEC:In 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