Medical devices are critical to the delivery of healthcare.

The term “Medical Devices”, as defined in the Health Products Act 2007, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of disease or abnormal physical condition.

Medical devices vary in complexity from simple products such as tongue depressors, surgical sutures and contact lenses to more complex devices such as implantable defibrillators, prosthetic heart valves and diagnostic imaging systems

• Overview

  Learn more about what is a medical device and the principles of classification of medical devices

• Regulatory Updates

  News updates, safety alerts on medical devices and guidance documents

• Regulatory Framework

  Provisions of the Contact Lens Practitioners Act, Radiation Protection Act, Medicines Act and Implementation of regulatory controls

• Adverse Event Reporting

  Learn more about adverse event reporting

• Field Safety Corrective Action Reporting

  Learn more about Field Safety Corrective Action Reporting

• Consumer Advice

  Learn more about contact lens care