India Medical Device Import Rules: Registration, Approval & Licensing

India Medical Device Import Rules: Registration, Approval & Licensing

$6.5 billion India medical device import market in 2025 is a regulatory tightrope, but CDSCO’s SUGAM portal has simplified the climb—think digital dashboards over dusty files. For foreign manufacturers and distributors, mastering India medical device import rules means nailing risk-based classification, appointing an Authorized Indian Agent (AIA), and securing Form MD-15 licenses. As CDSCO registration … Read more

Medical Device Import License in India: CDSCO Process, Documents & Fees Explained

Medical Device Import License In India: Cdsco Process, Documents &Amp; Fees Explained

India’s medical device import scene is exploding—valued at $6.5 billion in 2024 and projected to hit $10 billion by 2027—but snagging that elusive CDSCO import license is no walk in the park. With the Central Drugs Standard Control Organization (CDSCO) tightening the screws via Medical Device Rules (MDR) 2017 amendments, foreign firms face a gauntlet … Read more