Types of Medical Device Licenses in India & How to Get MD-42 in West Bengal
India has a structured regulatory system for medical devices under the Medical Devices Rules, 2017, governed by the Central Drugs Standard Control Organisation (CDSCO). Whether you are a manufacturer, importer, or distributor, obtaining the right Medical Device (MD) license is mandatory for compliance and business operations.
In this blog, we will cover the different types of MD licenses in India and a special focus on how to get the MD-42 license in West Bengal for trading and storing medical devices.
✅ What Are the Medical Device Classes in India?
Medical devices are categorized into four classes based on risk:
Class A – Low Risk (e.g., Thermometers, tongue depressors)
Class B – Low-Moderate Risk (e.g., Suction Equipment, Needles)
Class C – Moderate-High Risk (e.g., Bone fixation plates)
Class D – High Risk (e.g., Heart valves, ICU ventilators)
📋 Types of MD Licenses in India
Here are the main licenses issued under the Medical Devices Rules, 2017:
🔹 MD-5 License
Purpose: Manufacture of Class A & B devices
Authority: State Licensing Authority
Who Needs It: Small-scale manufacturers of low-risk medical devices
🔹 MD-6 License
Purpose: Manufacture of Class C & D devices
Authority: CDSCO (Central Licensing Authority)
Who Needs It: Large-scale manufacturers of high-risk devices
🔹 MD-9 License
Purpose: Import of Class A to D devices
Authority: CDSCO
Who Needs It: Importers bringing in devices from outside India
🔹 MD-15 License
Purpose: Wholesale or distribution
Authority: State Drug Controller
Who Needs It: Distributors, stockists
🔹 MD-42 License
Purpose: Retail sale, stock, exhibit, offer for sale, or distribute medical devices
Authority: State Licensing Authority
Who Needs It: Pharmacies, medical equipment stores, or institutions storing devices
🔹 MD-10 & MD-11 Licenses
MD-10: For manufacturing devices for testing/evaluation
MD-11: For importing devices for testing/evaluation
Authority: CDSCO
📍 How to Get MD-42 License in West Bengal?
To obtain the MD-42 license in West Bengal, follow these steps:
✅ Documents Required:
Receipt of Government Fees
Self-Certification of Good Distribution Practice
ID Proof (Aadhar Card/PAN Card)
Premises Ownership Proof (Rent Agreement/Sale Deed)
Competent Technical Staff’s Certificate & Experience Letter
Brief Description of Other Business Activities
Undertaking for Storage Compliance
📌 Where to Apply?
Authority: Drug Control Directorate, Government of West Bengal
Mode: Online application via cdscomdonline portal