MD-42 License in India: Complete Guide for 2025

📝 Introduction
If you're planning to trade, stock, or distribute medical devices in India, obtaining an MD-42 license is mandatory under the Medical Devices Rules, 2017. This license ensures your business complies with health and safety standards while selling regulated medical devices like contact lenses, surgical instruments, etc. This blog will walk you through the complete MD-42 license process, eligibility, documents required, and how PSR Compliance can assist you.

📌 What is MD-42 License?
The MD-42 license is issued by the Central Drugs Standard Control Organization (CDSCO) to authorize wholesalers, traders, or distributors of Class A and B medical devices. It is mandatory for:
Spectacle shops
Optical retailers
Medical device wholesalers
Distributors of non-notified and notified devices

✅ Who Needs MD-42 License?
If your business is involved in selling, stocking, exhibiting, or offering for sale of medical devices, you need this license—especially if your product falls under Class A or B category as per CDSCO classification.

Examples:
Contact lenses
Syringes
Digital thermometers
Glucometers
Surgical gloves

📃 Documents Required for MD-42 License
You will need the following documents to apply:
ID & Address Proof of Applicant
Constitution of the firm (Partnership/LLP/Company)
Drug Storage Declaration
Rental Agreement or Ownership Proof
Site Plan & Key Plan
Refrigerator Purchase Invoice (for temperature-controlled devices)
Details of Competent Technical Staff:
Degree/Diploma Certificate in Pharmacy or Science
Experience Certificate
List of Medical Devices to be dealt with
Covering Letter and Application Form in prescribed format

🏢 Eligibility Criteria
To apply for the MD-42 license:
You must have adequate storage space with proper conditions.
A registered pharmacist or a competent person with science background should supervise the sale.
Proper documentation and infrastructure as per CDSCO guidelines is required.

🧾 MD-42 License Fees (2025)
The government fee for MD-42 license is around ₹3,000 – ₹5,000 depending on the number of medical devices. Additional professional/consultancy charges may apply for documentation, site inspection, and liaisoning.

🖥️ How to Apply for MD-42 License Online?
Create an account on CDSCO’s SUGAM portal
Fill out the application form under Form MD-42
Upload documents and pay the government fees
Schedule inspection of premises (if required)
Receive MD-42 license approval upon verification

💼 How PSR Compliance Can Help
Getting an MD-42 license can be complex due to strict CDSCO norms. At PSR Compliance, we:
Assist with application drafting & document preparation
Guide you through CDSCO registration
Coordinate inspection schedules
Ensure error-free and fast-track approval
With years of experience in drug and medical license registration, our experts make the process smooth, affordable, and compliant.

👉 Read the full guide here: https://www.psrcompliance.com/blog/md-42-license-in-india