Global comparison of regulatory guidelines for personalized medical devices and identification of lacunae: Learning for Indian medical device ecosystem

Persistent innovation and technological advancements have popularized personalized devices in healthcare that are designed/ manufactured to meet the unique needs of individual patients. However, this rapid growth has raised concerns about the safety and quality of these devices entailing suitable and adaptable regulatory requirements. Although most countries across the globe have either implemented or are in process of doing so in near future, India still lags behind and the existing lacunae needs to be identified for enabling the medical device ecosystem to be in harmony with other countries. In this article, we aim to discuss the current state of the customized implant industry in India and the key lessons that can be learned directing towards opportunities for change to ensure its sustainable growth and development. Literature search in PubMed and Google Scholar following PRISMA guidelines using relevant search terms ‘medical device’ AND ‘regulation’ AND ‘Personalized Medical Devices’ AND ‘Custom made Devices’ OR ‘regulatory bodies’ yielded 36 articles. Only english language articles in journals and relevant data from authentic government portals available online was considered. The diverse regulatory framework across globe is witnessing persistent amendments since two decades. Accelerated use of personalized devices necessitates a proper streamlined regulatory framework providing clear definition and categorization of personalized device possessing single window clearance system, cost transparency, accredited laboratories, use of device identification systems, adequate post insertion record/ feedback database maintenance alongwith trained/ skilled workforce being assessed routinely.