Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific.

ABSTRACT

While some sort of regulatory convergence and harmonisation are often needed for achieving regulatory reliance, in reality, regulatory reliance as a strategy towards convergence and harmonisation has never been more significant in Asia-Pacific (APAC). A sustained, rapid and large-scale provision of medical devices, including articles and apparatus used in diagnosis, care, treatment or prevention of disease and softwares, etc, across national boundaries, is the key to winning the fight against future pandemics and improving people's well-being in such a populous and geographically diverse region. The COVID-19 pandemic highlighted the value of regulatory reliance to enable easier access to medical devices that have gone through regulatory approvals in countries with mature regulatory systems based on the Quality Management System and product assessment guidelines of the International Medical Device Regulators Forum. This analysis focuses on why regulatory reliance is needed, how much has been achieved, its impact on the development of the medical device industry and challenges to be addressed in the region. By drawing on the experience from the Singapore Health Sciences Authority-Thai Food and Drug Administration regulatory reliance pilot and Vietnam's inclusion of Korea Ministry of Food and Drug Safety and China National Medical Products Administration as reference markets for fast review/approval, it aims to explore next viable steps and future trend of the APAC regional regulatory harmonisation mechanism through regulatory reliance in the post-COVID-19 era.