ABSTRACT
Over the past decade, the Asia-Pacific region has grown to become an important player in global clinical research development and has contributed to the provision of quality clinical data to gain market access for new products. In recent years, more regional regulators have too been turning their focus on the regulation controls required for medical device clinical trials. Medical devices varey in complexity and would include a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of disease or abnormal physical condition. Medical devices with pharmaceutical components may be categorised as a combination product or a medical device or a pharmaceutical product. In the medical device context, the investigational device is but part of a complex system comprising the device, the instrumentation or accessory devices and the procedure for using the device.
