Navigate Your Medical Device Entry into India
An interactive guide to the regulatory framework, strategic decisions, and compliance requirements for one of the world's fastest-growing healthcare markets.
$30B
Projected Market by 2030
~80%
Reliance on Imports
The Regulatory Landscape
India's regulatory framework for medical devices is governed by the CDSCO under the MDR 2017. This modern, risk-based system aligns with global standards and has shifted towards a streamlined, digital-first approach through the NSWS and SUGAM portals to ensure safety, quality, and ease of doing business.
CDSCO
The Central Drugs Standard Control Organisation is India's apex regulatory body. It's responsible for approving new devices, regulating clinical trials, issuing import licenses, and overseeing post-market surveillance.
Medical Device Rules (MDR) 2017
This is the core legislation. It introduced a risk-based classification (Class A, B, C, D), mandated Quality Management Systems (QMS) aligned with ISO 13485, and expanded regulation to all medical devices.
Digital Portals (NSWS & SUGAM)
The National Single Window System (NSWS) and the SUGAM portal are the digital gateways for all regulatory submissions, creating a unified, transparent, and efficient online system for license applications.
Choose Your Market Entry Strategy
A foreign manufacturer cannot apply for a license directly. You must establish a local legal entity. This is your most critical strategic decision, impacting control, cost, and long-term flexibility. Compare the two primary models below to determine the best fit for your business goals.
Wholly Owned Subsidiary (WOS)
An entity incorporated in India, fully owned by your parent company. The recommended path for long-term commitment and growth.
Indian Authorized Agent (IAA)
A local third-party firm appointed via Power of Attorney to manage regulatory affairs on your behalf. Ideal for initial market testing.
| Feature | Subsidiary (WOS) | Authorized Agent (IAA) |
|---|---|---|
| Initial Setup | Higher cost, 2-3 month timeline | Lower cost, faster to market |
| Control over Distribution | Full Control. You own the license and can appoint/change multiple distributors freely. | Limited. The agent owns the license. Changing agents requires a complete re-registration. |
| Legal Liability | Limited to the subsidiary's assets. Parent company is protected. | Agent assumes legal responsibility for the device in India. |
| Tax Implications | Lower corporate tax rate (22-30%) | Higher rates (up to 40%) may apply |
| Best For | Long-term, large-scale market penetration and brand building. | Market testing or initial, low-volume entry with minimal investment. |
The Regulatory Pathway to Your Import License
The journey to obtaining the mandatory MD-15 Import License follows a clear, risk-based process. The classification of your device is the first and most crucial step, as it dictates the required documentation, fees, and approval timeline. Click through the steps below to explore the requirements for each phase.
Device Classification
Technical Documentation
Application & Fees
Step 1: Device Classification & Timelines
India uses a four-tier, risk-based classification system. Low-risk devices (A & B) are handled by State Licensing Authorities (SLA), while high-risk devices (C & D) are managed by the Central Licensing Authority (CLA). This classification directly impacts the approval timeline.
Class A: Low Risk
Devices with a low risk profile and a straightforward design. They pose minimal threat to a patient's health.
Examples: Bandages, thermometers, tongue depressors, cotton swabs.
Post-Market Compliance & Commercial Strategy
Gaining market access is only the beginning. Sustained success in India requires a robust post-market compliance framework and a clear understanding of the commercial landscape, from pricing controls to government procurement channels.
Adverse Event Reporting
Your local entity (WOS/IAA) is legally required to report all adverse events to the CDSCO through the Materiovigilance Programme of India (MvPI). Prompt and accurate reporting is mandatory.
Post-Market Surveillance
A proactive Post-Market Surveillance Plan (PMSP) is required for Class B, C, and D devices to continuously monitor product safety and performance in the market.
License Renewal
The MD-15 Import License is valid for five years. A retention fee must be paid and updated documentation submitted before expiration to ensure uninterrupted market access.
Pricing & Reimbursement
The National Pharmaceutical Pricing Authority (NPPA) may cap the trade margin on certain devices (e.g., glucometers, nebulizers) to ensure affordability. This must be factored into your pricing strategy.
Distribution Channels
India's vast market often requires a network of regional distributors. A WOS provides the flexibility to manage these partnerships effectively without regulatory hurdles.
Government Procurement
To participate in public tenders, you must register on the Government e-Marketplace (GeM). Be aware of the "Make in India" preference policy, which favors locally manufactured products.