Navigating Import Permissions for Innovative Medical Devices Without a Predicate in India
In the ever-evolving world of healthcare, the development and introduction of new medical devices play a pivotal role in enhancing patient care and advancing medical science. However, before such innovative devices can reach healthcare professionals and patients, they must achieve compliance with a comprehensive Regulatory framework. In India, securing a manufacturing or import license for new medical devices is a multifaceted process that involves compliance with stringent rules and regulations.