2025 Guide to MD-42 License: Documents, Process & Compliance Tips

Imagine you run a medical equipment business — you stock, display, or distribute devices like surgical tools, diagnostics kits, or other “notified medical devices.” You can’t just go ahead and sell them without permission. That’s where the MD‑42 license comes into play.

In India, under the Medical Devices Rules (2017) and the Drugs & Cosmetics Act, certain medical devices are “notified,” meaning they need extra regulatory oversight. To legally stock, exhibit, or distribute these devices, you’re expected to hold an MD‑42 license issued by the State Licensing Authority (SLA). Without it, you risk penalties, product seizure, or shutdowns.

So, in short: if medical devices are your business, MD‑42 isn’t optional — it’s mandatory.

Who Needs to Get an MD‑42 License?

Let me break this down simply. The following entities need to apply for MD‑42:

• Distributors or wholesalers of medical devices
• Dealers or stockists who store them for resale
• Exhibitors who showcase medical devices at fairs or trade shows
• Anyone who wants to legally distribute medical devices across states

It doesn’t matter whether you're big or small — if your business involves medical devices that fall under the “notified” list, MD‑42 licensing is required.

Also, your business must meet certain eligibility criteria — your entity must be legally registered (say, a private limited company, LLP, or proprietorship), have proper storage facilities, and possibly employ trained technical staff to oversee compliance.

What Documents You’ll Need

Getting MD‑42 isn’t just about filling a form. You’ll need a bunch of documents to back your application. Here’s a checklist to guide you:

1. Business Proof – Registration documents (Incorporation certificate, partnership deed, etc.), plus tax/PAN/GST info.
2. Address Proof – Lease agreement or ownership papers for your premises.
3. Authorization Letter – If you're distributing someone else's medical devices, you need permission from the manufacturer.
4. Affidavit / Declaration – Self‑declaration of compliance with medical devices rules.
5. Technical / Key Personnel Info – Educational/experience proofs of the people handling medical device operations.
6. Site Master File / Storage Details – Documents specifying how devices are stored, handled, quality checks, etc.
7. Medical Device Registration Certificate – If your product is a notified device, you’ll need the registration certificate.
8. Other licenses or NOCs, depending on state rules.

Missing or incorrectly filled documents are among the most common reasons for rejections, so it pays to double-check everything.

Step‑by‑Step: How to Apply for an MD‑42 License

Let’s walk through the process, step by step, so it doesn’t feel like wandering in the dark.

Step 1: Prepare the Application (Form MD‑41)

You fill out Form MD‑41 — this is the basic application form for MD‑42. You’ll find it either on the website of CDSCO (Central Drugs Standard Control Organization) or on the State Drug Control Department’s portal (depending on your state). Along with the form, you attach all the documents listed above.

Step 2: Pay the Application Fee

Each state has its own fee structure depending on whether you’re a distributor, wholesaler, or exhibitor. After filling the form, you’ll need to submit the prescribed fee. Often this can be done online through the same regulatory portal.

Step 3: Inspection by State Licensing Authority (SLA)

Once your application is in, the State Licensing Authority will typically conduct a physical inspection of your premises. They’ll verify:

• Storage conditions (temperature, humidity control if needed)

• Quality control processes

• Record-keeping

• Whether the premises match the site master file and declared layout

Be ready for them to ask for clarifications or minor corrections.

Step 4: Granting the License

If everything checks out, the SLA will issue your MD‑42 license. Typically, this happens within 30 to 45 days, but timelines can vary by state. Once granted, the license is valid for 5 years, after which you'll need to renew.

Obligations and Compliance After You Get the License

Getting MD‑42 is not the finish line — you’ve got ongoing responsibilities:

• Record-Keeping: Maintain logs of purchases, sales, distribution, and recalls (if any).

• Labeling & Quality Standards: Products should comply with labeling norms and quality standards like ISO 13485.

• Periodic Inspections: Authorities may revisit your records or premises.

• Renewal: Before the 5‑year term ends, you must apply for renewal.

• Regulations Updates: Be ready to adapt if CDSCO or state rules change.

If you slack in any of these, you can face penalties or even license cancellation.

Real-World Challenges You Might Face

From my experience, these are some common hurdles businesses run into:

• Documents get rejected because of small errors or mismatches

• The inspection doesn’t go well (premises not matching the declared layout)

• Delays in getting manufacturer authorization letters

• Differences between states — rules vary slightly from one state to another

• Confusion about which medical devices are "notified"

So it's not just about filling forms — it’s about being consistent, precise, and compliant across every step.

Why Having MD‑42 Helps Your Business

Let’s talk benefits — not just legal requirements.

• Legitimacy & Trust: Hospitals, clinics, and clients prefer dealing with licensed entities.

• Avoid Legal Trouble: No fines, no product seizure, no shutdown notices.

• Expand Reach: With a license, you can distribute across states without too much resistance.

• Business Growth: You can bid for institutional contracts, supply agreements, etc., which often demand regulatory compliance.

It’s an investment that gives you credibility and peace of mind.

How PSR Compliance Can Help You

Navigating MD‑42 licensing can feel overwhelming—lots of steps, technicalities, and legal details. That’s exactly where PSR Compliance steps in with hands-on support:

• End-to-end guidance: From assessing your eligibility to getting your license, they manage each step.

• Document preparation & review: They’ll help you prepare all required documents (authorization, site master file, storage plans) so nothing is left out or wrongly filled.

• Liaising with regulators & SLA: They coordinate with state authorities, handle clarifications, and follow up, reducing your back-and-forth.

• Facilitating inspections: They help you set up premises as per guidelines, guide quality systems, and make sure inspections pass smoothly.

• Renewal & compliance support: After license issuance, they keep you compliant, track deadlines, help prepare for renewals, and stay updated on regulatory changes.

In short, PSR Compliance can save you time, reduce errors, and make the whole process much less stressful.

If you want to get started on your MD‑42 license or want expert help across the journey, you can reach out here:

👉 https://www.psrcompliance.com/blog/md-42-license-in-india