If you're in the business of selling, stocking, or distributing medical devices in India, there’s one thing you absolutely can’t skip—getting an MD‑42 license. Whether you're a wholesaler, a distributor, or even selling on an e-commerce platform like Amazon or Flipkart, this license is mandatory. It ensures you're legally allowed to deal in medical devices under Indian regulatory laws.
But don’t worry—it’s not as complicated as it sounds. Let’s break it down in simple terms so you know what it is, who needs it, how to get it, and why it matters.
What is an MD‑42 License?
The MD-42 license is an official approval granted by the government that allows you to stock, sell, exhibit, or distribute medical devices in India. It’s part of the compliance system governed by the Medical Devices Rules, 2017, and is issued through state licensing authorities under the supervision of CDSCO—the Central Drugs Standard Control Organization.
If you’re handling any medical devices—whether they're thermometers, diagnostic kits, surgical gloves, or advanced diagnostic machines—you need this license to legally operate.
Who Needs the MD‑42 License?
This license is essential for businesses involved in the supply chain of medical devices, including:
Medical device wholesalers and distributors
Retailers or medical shops selling devices
Online sellers on platforms like Amazon, Flipkart, and others
Stockists and exhibitors showcasing devices at trade shows
Importers who distribute devices within India
Companies operating multiple warehouses or locations (each site needs its own license)
In short, if you’re doing anything beyond personal use of a medical device, chances are you need this license.
Why is the MD‑42 License So Important?
Legal Protection
Operating without the proper license can lead to fines, product seizures, and even shutdowns. With an MD‑42 license, your business runs legally and securely.Trust and Credibility
Holding an authorized license builds trust among suppliers, hospitals, and customers. It shows that your business is legitimate and compliant with Indian laws.Access to Bigger Markets
Large hospitals, pharma chains, and even government contracts often prefer working with licensed suppliers. It opens doors to scale up.Required by Online Platforms
E-commerce giants like Amazon and Flipkart now demand the MD-42 license before listing any medical device. Without it, your product listings may get removed or blocked.Seamless Operations
With a license in place, you avoid legal hiccups and can focus more on growing your business instead of fighting compliance battles.
Basic Eligibility Criteria
Before you apply, make sure you check these boxes:
Your business must be registered (Proprietorship, LLP, Pvt Ltd, etc.)
You should have a physical location or warehouse that meets government standards
A qualified technical person should be employed—either a pharmacist, or someone with a science degree or equivalent experience
Your facility must maintain Good Distribution Practices (GDP) such as clean storage, proper record-keeping, and safety measures
If you're not the manufacturer, you may need authorization from the manufacturer of the devices you plan to distribute
Documents Required for MD‑42 Registration
When you’re ready to apply, here’s what you’ll need:
Certificate of Incorporation / Business Registration
Address proof of your warehouse or store
Identity and qualification proof of the technical staff
Storage layout or site plan of your premises
List of medical devices you plan to distribute or sell
A declaration of compliance with Good Distribution Practices
Authorization letter (if you’re selling third-party products)
Payment receipt of government fee
Keeping your documents clean, complete, and correctly formatted is key to avoiding delays.
Application Process: Step-by-Step
Register on the CDSCO SUGAM Portal
This is the official portal where all applications are submitted digitally.Fill Out Form MD‑41
This is the application form where you’ll provide business details, address, staff info, and product list.Upload the Required Documents
Scan and upload each document as per the format mentioned.Pay the Government Fee
The standard fee for MD‑42 license is ₹3,000 per location. This can be paid online during the application process.Inspection by State Authority
Once submitted, your application will be reviewed and a physical inspection of your premises may be scheduled.Get Your MD‑42 License
After successful inspection and document verification, your license is issued. This can usually be downloaded digitally.
Validity and Renewal
Although the MD‑42 license is often referred to as "lifetime," it's important to know that it must be retained every 5 years by paying a retention fee. If you fail to do this, your license can be canceled or suspended.
Also, if you change your address, add new products, or make any structural business changes, you must update the licensing authority by submitting a modification request.
Best Practices After Getting the License
Once you have your MD‑42 license, your responsibility doesn’t end there. Here are a few things you should continue doing:
Display your license at your place of business and attach it to online listings
Keep accurate sales and stock records
Maintain proper storage conditions for medical devices
Renew or update the license on time
Stay informed about any regulatory changes or amendments to the Medical Devices Rules
Doing these consistently will help you avoid penalties and maintain long-term compliance.
Common Mistakes to Avoid
Submitting incomplete or outdated documents
Failing to appoint a qualified technical person
Assuming the license is permanent and not paying the retention fee
Applying for one site while operating from multiple warehouses
Ignoring post-approval compliance requirements or audit visits
Being proactive and accurate in your application can save a lot of future headaches.
Frequently Asked Questions
1. How long does it take to get the MD‑42 license?
Usually between 15–30 days, depending on how fast your documents are processed and inspection is completed.
2. Can I sell medical devices online with the MD‑42 license?
Yes. You’ll need to provide the license to platforms like Amazon or Flipkart before listing products.
3. What’s the government fee for the MD‑42 license?
Currently, it’s ₹3,000 per premise.
4. Can I apply without a physical office or warehouse?
No, a valid premise with storage capability is mandatory.
5. Do I need this license for Class A or B medical devices only?
It’s required for Class A and B. Higher classes may require additional approvals.
Final Words
The medical device sector is growing fast—and so are the regulations that come with it. Whether you’re just starting out or scaling an existing distribution setup, the MD‑42 license is a non-negotiable part of doing business legally and professionally in India.
It protects your brand, builds customer trust, and unlocks access to wider sales opportunities, both offline and online.
For more information visit:
👉 https://www.psrcompliance.com/md-42-license
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