ABSTRACT
The role of the Regulatory Affairs department is evolving from that of a subject matter expert to becoming a business partner working closely together with the commercial team and other departments in order to ensure the successful implementation of the company's strategies. The Asia Regulatory Affairs team plays an increasingly important role in relation to the commercial team and other departments, and through all the different stages of the product life. For many medical device products, the North American and Western European markets are slow growing, while the competition is fierce, customers are increasingly cost conscious when healthcare spending is under scrutiny, and markets are saturated. From a broad industry perspective, this will require improved collaboration between all stakeholders in the field, including regulators, health ministries, academics, healthcare providers, business executives, and patient groups. In larger organizations that manage broad product ranges and many geographical markets, the number of product registration activities to manage quickly becomes significant.
