ABSTRACT
Medical devices vary 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. Proper change management coupled with effective organisational strategy for regulatory affairs and clinical research will help to cushion the impact of clinical changes and prepare the industry to take on the challenges of a changing regulatory landscape. Many similarities exist between medical device clinical trials and pharmaceutical clinical trials. The scope and strategy for regulation of medical device clinical trials varies within the Asia-Pacific region. While regulatory affairs professionals from the Sponsor organisations have guidance on the scope of their responsibility, those from the regulatory authorities need to establish their specific role and responsibilities within their own clinical research environment. Industry stakeholders who often take on the role of the Sponsor or clinical research organisations are watching clinical developments closely.
