As the medical device sector embraces digital transformation, the shift towards electronic labels (e-Labels) and electronic Instructions for Use (e-IFUs) offers a path to greater efficiency, sustainability, and an improved user experience. However, in the APAC region, the journey towards these digital solutions is met with complex regulatory challenges that require careful navigation by industry members and regulators.

This position paper by APACMed outlines the current regulatory landscape, the challenges associated with managing paper labels, and the benefits of digital alternatives. Drawing on insights from a detailed survey of APACMed members, it highlights the diverse regulations across the region and delay in the adoption of e-Labels and e-IFUs.

The paper concludes with actionable recommendations aimed at harmonising regulations, enhancing collaboration, and providing clearer guidance to support the adoption of electronic solutions. By working together, industry and regulators can streamline processes, reduce costs, and improve access to vital information for healthcare providers and patients across the APAC region.