India’s medical device market is one of the fastest growing in the world, According to Invest India, India’s medical device market valued at around USD 11 billion in 2022–23, is projected to reach USD 50 billion by 2030, growing at a CAGR of approximately 16.4% [Report]. As global manufacturers and startups set their sights on this high-potential market, regulatory compliance becomes the pivotal differentiator between accelerated market entry and lengthy delays.