What Is an MD-42 License & Why Every Medical Device Seller Needs It

Let’s be honest — regulatory stuff can get overwhelming. Especially when you’re just trying to run your business and suddenly someone tells you, “Bhai, MD-42 license toh mandatory hai!” And you’re like… MD what now?

If you’re dealing with medical devices in any way — selling, distributing, storing, or even listing them online — you’ve probably heard about the MD-42 license. But if you haven’t fully wrapped your head around it yet, this blog’s for you.

What is the MD-42 License?

In simple words, MD-42 is the official license you need to legally sell or distribute medical devices (mostly low to medium risk) in India. It’s issued under the Medical Devices Rules, 2017, and it’s regulated by CDSCO (Central Drugs Standard Control Organization).

It’s not optional. It’s not “good to have.” It’s mandatory — especially if you deal with Class A and Class B devices.

Wait, what are Class A & B devices?

Good question. The medical devices industry is split into 4 risk categories:

• Class A: Low risk (like thermometers, bandages)
  
  

• Class B: Low to moderate risk (like blood pressure monitors)
  
  

• Class C & D: Higher risk (like X-ray machines, ventilators)
  
  

If you're handling Class A or B products — which includes a massive list of commonly sold items — you need the MD-42 license to stock, sell, or distribute them legally.

Who Needs the MD-42 License?

You need it if you are:

• A retailer selling medical devices at a shop or pharmacy
  
  

• A wholesaler/distributor supplying devices to hospitals or resellers
  
  

• An importer planning to sell in the Indian market
  
  

• An online seller listing medical devices on Amazon, Flipkart, etc.
  
  

• A stockist or exhibitor showcasing devices in expos or medical trade fairs
  
  

Even small-scale sellers and e-commerce stores are not exempt. Yes, even if you’re only selling a few blood glucose meters from your warehouse in Noida — you’re still required to be licensed.

Why is this License Important?

Imagine this:

You’ve stocked ₹5 lakhs worth of medical devices. A client calls. They're ready to buy. But then, your e-commerce platform or supplier asks, “License dikhao?”
And boom. No license. Deal gone.

It’s not just about legal risks — not having the MD-42 license can:

• Get your products delisted from platforms
  
  

• Stop you from expanding into hospitals or pharma networks
  
  

• Result in fines, seizure, or even legal action
  
  

On the flip side, having the license shows you're compliant, trustworthy, and professional.

Documents Required for MD-42 License

Don’t worry — it’s not as scary as it sounds. Here’s what you typically need:

• Basic business registration (GST, PAN, company/firm docs)
  
  

• Premises proof – rent agreement or property paper
  
  

• Details of your storage area (layout, temperature control if needed)
  
  

• Competent technical staff – usually a science graduate or pharmacist
  
  

• List of medical devices you’re handling
  
  

• A filled Form MD-41 (the application form)
  
  

Important: The staff member listed must be trained or experienced in handling medical devices — that’s a key eligibility condition.

How to Apply (Step-by-Step)

Here’s how the application process usually works:

1. Prepare your documents – business proof, site plan, staff credentials, etc.
   
   

2. Register on the SUGAM portal – this is the CDSCO’s online platform.
   
   

3. Fill out Form MD-41 carefully – include device details, address, and staff info.
   
   

4. Pay the application fee – usually ₹3,000 per premise.
   
   

5. Site inspection – licensing authority may visit your place.
   
   

6. Get the license – if all goes well, you’ll get your MD-42 certificate.
   
   

Once issued, the license is valid indefinitely, but a retention fee is required every 5 years to keep it active.

Common Mistakes People Make

From experience, these are the top things that delay or mess up the approval:

• Submitting incomplete documents or wrong file formats
  
  

• Listing unqualified staff or no staff at all
  
  

• Ignoring storage conditions (especially for temperature-sensitive items)
  
  

• Not responding to authority queries on time
  
  

• Classifying devices incorrectly (putting a Class C device under MD-42)
  
  

Pro tip: Double-check everything. And if this feels too much, getting professional help is 100% worth it.

What Happens if You Don't Get It?

Honestly, nothing good.

You may fly under the radar for a while, but the moment your product hits a major platform, a hospital network, or government buyer — you’ll be asked for it.

And if you don’t have it:

• You can’t sell legally
  
  

• You may get blacklisted from portals
  
  

• Penalties can run into lakhs
  
  

So yes, it's worth getting done properly.

Why Businesses Prefer Getting Expert Help

Look, we get it. You’re running a business. You don’t have time to decode confusing regulations or sit on hold with the licensing office.

That’s why most serious sellers choose to go through experienced compliance consultants who:

• Help with document prep and validation
  
  

• Ensure your forms are filled error-free
  
  

• Coordinate with the authority during inspection
  
  

• Handle follow-ups and even retention filing
  
  

It’s a one-time investment that saves you a lot of time, money, and rejections.

How PSR Compliance Can Help with MD-42 License

PSR Compliance simplifies the entire MD-42 licensing process for medical device sellers and distributors. From checking your eligibility to preparing documents, submitting the application on the CDSCO SUGAM portal, and coordinating inspections — they handle it all. Their experts ensure error-free filing, save you time, and help avoid common rejections. Whether you're applying for the first time or need help with license renewal, PSR Compliance provides end-to-end support.

🔗 Learn more on https://www.psrcompliance.com/md-42-license

EPR Registration for Plastic Waste: A Complete Guide for Indian Businesses

Let’s be honest—most of us don’t think about where our plastic packaging ends up once it leaves our hands. But as businesses, especially those involved in manufacturing or packaging, we no longer have that luxury.

If you're a business that uses plastic—whether you're producing it, importing it, or simply using it to package your products—you need to understand one thing clearly: EPR registration is no longer optional.

And no, it's not just more government paperwork. It's part of a much larger shift in how India is handling its plastic waste problem. Let’s break it down in simple terms.

What Exactly is EPR?

EPR stands for Extended Producer Responsibility.

In plain English? It means you make it, you take responsibility for what happens to it after use.

If your business makes or sells products that use plastic packaging, you're now responsible for what happens to that plastic once the product is used. That includes collection, recycling, and even disposal, depending on the type of plastic.

This isn't just a CSR initiative—it’s backed by India’s Plastic Waste Management Rules, and it's enforced by the Central Pollution Control Board (CPCB). So yes, it has legal weight.

Who Needs to Register for EPR?

Here's a quick list of businesses that must register for EPR:

• Producers – You manufacture plastic packaging materials.
  
  

• Importers – You import plastic packaging or plastic-containing products.
  
  

• Brand Owners – You sell products under your own brand name, whether or not you manufacture them.
  
  

• Plastic Waste Processors – You handle recycling, co-processing, or disposal of plastic waste.
  
  

If you fall into one of these categories, congratulations—you’re eligible (and legally obligated) to get yourself EPR registered.

Why Is EPR Registration Important?

Let’s not sugarcoat it—plastic waste is a massive issue in India. From overflowing landfills to clogged rivers and microplastics in our food, we’re dealing with serious environmental and health consequences.

The government’s response is firm: you put it into the market, you help clean it up.

Still need convincing? Here’s why EPR matters:

1. It’s Mandatory – Failing to register or comply can lead to fines, legal action, or worse—your products being barred from the market.
   
   

2. It Builds Trust – Consumers care about sustainability. Showing that you’re compliant makes your brand look responsible.
   
   

3. It Keeps You Market-Ready – Many online platforms and retailers now require proof of EPR compliance.
   
   

4. It Future-Proofs Your Business – Regulations around sustainability are only going to get stricter. Getting EPR-compliant now puts you ahead of the curve.
   
   

Real Talk: The Registration Process

Now you might be wondering—what’s the process like? Is it complicated?

Short answer: it can be, especially if you're navigating it for the first time. But once you understand the basics (or get professional help), it becomes manageable.

Here’s a simplified breakdown:

✅ Step 1: Know What You’re Dealing With

First, calculate your annual plastic usage—how much packaging you're putting into the market. This could be rigid plastic, multi-layered plastic, compostable plastic, etc.

✅ Step 2: Register on the CPCB Portal

This is where you officially apply for EPR registration. You’ll need to create an account and fill in all your business and product-related details.

✅ Step 3: Upload Required Documents

Typical documents include:

• GST certificate
  
  

• Company PAN
  
  

• Authorized signatory ID
  
  

• Details of plastic packaging (type and quantity)
  
  

Be accurate here. Mistakes or incomplete info can delay approvals.

✅ Step 4: Define Your EPR Targets

Once registered, you’ll be assigned targets—basically, the percentage of plastic you must collect or recycle based on your usage.

✅ Step 5: Partner With Recyclers or Waste Management Agencies

You’re not expected to do it all yourself. You can tie up with authorized plastic waste processors, buy EPR credits, or set up your own take-back systems.

✅ Step 6: File Annual Returns

Every year, you need to report how much plastic waste you’ve managed—proof of collection, recycling, etc.

Common Mistakes Businesses Make (And How to Avoid Them)

Here’s where many people trip up:

• Waiting till the last minute – Start early; CPCB approvals can take time.
  
  

• Incomplete documentation – A small missing detail can hold up your entire application.
  
  

• Tying up with unregistered recyclers – Only work with CPCB-registered processors.
  
  

• Ignoring ongoing compliance – It’s not one-and-done; you’ll need to report annually.
  
  

A Quick Example to Make It Real

Let’s say you run a cosmetics brand that ships thousands of face creams in plastic jars each month. Even if you’re just using plastic as packaging, you’re responsible under EPR.

You’ll need to register, calculate how much plastic you use per year, and show proof that you're taking steps to collect or recycle an equivalent amount. That might mean hiring a third-party waste management agency or partnering with a recycler who gives you EPR credits.

Is This Only for Big Companies?

Nope. Even small businesses and startups are expected to comply. The government has made it clear—size doesn’t matter when it comes to environmental responsibility.

What If You Don’t Comply?

That’s risky. CPCB has already started cracking down on non-compliant companies. You could face:

• Hefty fines
  
  

• Legal notices
  
  

• Product delisting from marketplaces
  
  

• Suspension of operations in extreme cases
  
  

Don’t wait for a warning letter. It’s better to be proactive.

How PSR Compliance Can Help You Get EPR Registered 

EPR registration can feel like a maze—portals, documents, recycling tie-ups, annual reporting... it’s a lot. That’s where PSR Compliance steps in. They handle the entire process for you—from preparing your documentation, filing your application on the CPCB portal, calculating your plastic waste obligations, to helping you connect with authorized recyclers.

In short, they make sure you stay compliant while you focus on running your business.

Want details? Visit : https://www.psrcompliance.com/epr-registration-for-plastic-waste