Let’s be honest — Indian medical regulations can feel like a maze. And if you're new to the whole medical devices business, all these forms and licenses might sound intimidating. But hang in there — once you understand what MD-42 registration is (and what it isn’t), it’s actually not that bad.
This post will walk you through what the MD-42 license is, who needs it, how to apply, and what you need to watch out for — in plain English.
First of All, What Even Is an MD-42 License?
Think of it like this: if you're running a shop (physical or online), and you're selling medical devices — even something simple like a thermometer — the government wants to know that you’re doing it right.
That’s where the MD-42 license comes in.
It’s basically a permission slip from CDSCO (the regulatory body for drugs and devices in India), saying:
"Yes, this business is allowed to sell or distribute Class A and Class B medical devices."
That includes stuff like:
BP monitors
Glucometers
Surgical gloves
Face masks
Oxygen flow meters
So if your business touches any of that, you probably need to get your md42 registration sorted.
Who Actually Needs MD-42 Registration?
Here’s a simple rule:
If you’re not manufacturing the product, but you’re selling, distributing, or even just storing it for sale — you need the license.
That means:
Distributors
Stockists
E-commerce platforms
Retail medical stores
Hospital supply vendors
Even if you're running a home-based business, and selling online — if it involves regulated devices, you’re in.
What Is Form MD (a.k.a. Form MD-42)?
This is the form you fill out when applying for the MD-42 license. You do it through the CDSCO online portal, and it’s not as complicated as it sounds.
You’ll need to give your:
Business details
Warehouse or shop address
Details of your "competent person" (more on that in a second)
Supporting documents
MD-42 Registration Process (Step by Step, No Fluff)
Here’s how the md-42 registration online process works, simplified:
Step 1: Sign Up on the CDSCO Portal
Go to cdsco.gov.in, click on SUGAM portal, and create an account. Use your official business email.
Step 2: Fill Out Form MD-42
This is where you mention your business name, contact details, product categories, storage facility, etc.
Step 3: Upload Required Docs
You’ll usually need:
Business address proof
Qualification of your technical person (e.g., D. Pharma or B.Sc. Bio background)
Site photos
Equipment details (if storing temperature-sensitive items)
Declaration letter
Step 4: Pay the Government Fees
Varies slightly by state, but expect around ₹3,000 to ₹5,000.
Step 5: Site Inspection (Sometimes)
Some states may send an inspector to verify your setup. Keep things in order — especially storage and hygiene.
Step 6: License Issued
Once approved, you’ll get a soft copy of your md42 license on the portal.
What Is a “Competent Technical Staff”?
This is a person responsible for maintaining quality and records. They don’t need to be a full-time pharmacist, but they must have a relevant qualification and some understanding of medical devices.
For example:
If your cousin has a B.Sc. in Microbiology and helps out with the business, you can list them (with documents) as the technical person.
How Long Does It Take?
If all your documents are in order, and there’s no site inspection delay, you can get your md 42 license in 4 to 6 weeks.
Sometimes it’s faster, sometimes slower — depends on the state authority.
Validity & Renewal
Your MD-42 license stays valid for 5 years. Just don’t forget to renew it before it expires (ideally 3–6 months in advance), because if it lapses, you may have to start the whole process again.
Real Talk: Common Mistakes People Make
Let me save you some time (and headaches). These are the most common blunders:
Uploading blurry or incomplete documents
Mentioning the wrong device category (use CDSCO’s classification guide!)
Using a personal address as business premises (risky)
Skipping the qualified staff requirement
Not checking email updates from CDSCO
Triple-check everything before you hit “submit.”
For more information visit : https://www.psrcompliance.com/blog/md-42-license-in-india
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