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. Even though the most remarkable growth has been observed mainly in pharmaceutical clinical trials, industry stakeholders have recognised the high potential of medical device clinical trials which have hitherto been unregulated in most Asia-Pacific countries. In recent years, more regional regulators have too been turning their focus on the regulation controls required for medical device clinical trials. As both regulators and industry stakeholders seek for direction in this changing landscape, there is a generated demand for regulatory affairs professionals
to participate actively in this quest, and work synergistically with their clinical research colleagues, to ensure that any additional regulatory controls would be better managed without impeding the path to market access for new medical devices. It is therefore pertinent for regulatory affairs professionals to gain a good understanding of medical device clinical trials and develop expertise in related regulatory requirements.
