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

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Presentation transcript:

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

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

Quality System  ISO  US Quality System Regulation  CANADA  JGMP  GMP

Examples of Harmonized European Standards for Medical Devices  EN : Medical Electrical Equipment  EN ISO : Biological evaluation of medical devices  EN ISO : Quality management system – Requirements for regulatory purposes  EN ISO /2: Clinical investigation of medical devices for human subjects  EN ISO : Medical devices – Application of risk management to medical devices

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

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

Essential Requirements  Traceability, Optical properties (IOL, Laser … )  Compatibility with accessories  Risk management  Labeling, instructions for use, symbols

Satisfy Customer Focus Meet Regulatory Obligation Thank you