ABSTRACT
Asia-Pacific is a widely diverse region with a complex and rapidly changing regulatory environment. For medical device companies, this is a double-edge sword as compliance with ever-changing regulatory standards is quite costly and adds stress to an organization. By investing in an effective regulatory affairs (RA) organization and integrating it with the business planning process, a company will benefit from a competitive advantage in four areas: time to market, barriers of entry, continuity of business, and best use of resources. Continuity of business is best achieved through anticipation and planning: anticipation of a change of regulatory status of an existing product, or anticipation of a change in the regulatory landscape. The RA team is always considered a key partner to the business within medical device companies, due to its responsibility for ensuring appropriate and fast product registration. Integrating regulatory affairs in business planning requires rethinking the role of the RA professional, moving from a reactive model to a consultative approach.
