India Medical Device Import Rules: Registration, Approval & Licensing

India Medical Device Import Rules: Registration, Approval & Licensing

Unlocking India’s $6.5 billion 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 … Read more

CDSCO Medical Device Import Regulations in India: Everything You Must Know

Cdsco Medical Device Import Regulations In India: Everything You Must Know

India’s medical device market is a powerhouse, importing $6.5 billion worth in 2024 and forecasted to surge to $10 billion by 2027, driven by rising healthcare demands and government initiatives like Ayushman Bharat. But unlocking this potential requires navigating the Central Drugs Standard Control Organization (CDSCO)’s stringent import regulations under the Medical Devices Rules (MDR) … Read more

Importing Medical Devices in India | A Complete Guide for Manufacturers & Distributors

Importing Medical Devices In India | A Complete Guide For Manufacturers &Amp; Distributors

India’s medical device sector is a juggernaut, clocking $6.5 billion in imports last year and eyeing $10 billion by 2027, fueled by a 1.4 billion-strong population and booming healthcare infrastructure. But breaching this market demands mastery of the Central Drugs Standard Control Organization (CDSCO) framework under the Medical Devices Rules (MDR) 2017—updated in 2025 with … 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

How to Import Medical Devices in India: Step-by-Step CDSCO Guide (2026 Update)

How to Import Medical Devices in India: Step-by-Step CDSCO Guide (2026 Update)

Navigating India’s booming $15 billion medical device market just got smarter with CDSCO’s streamlined digital push—foreign manufacturers, take note: a single portal now fast-tracks your entry, but miss a form, and your shipment stalls at Mumbai’s docks. As CDSCO import license demands surge amid 2025’s in-country testing mandates for high-risk IVDs, this guide breaks down … Read more