(Introduction)

Planning to start a wholesale business of medical devices in India? 🏥
But here’s the biggest question — do you have a Medical Device Wholesale License?

Without this license, your business is completely illegal, and you may face penalties, product seizure, or even business shutdown. ❌

Many businesses fail or get delayed simply because they don’t understand the correct Medical Device Wholesale License Registration process.

👉 Don’t worry.
In this complete 2026 guide, you will learn everything — process, documents, fees, eligibility, and expert tips to get your license quickly and without mistakes.

What is Medical Device Wholesale License?

A Medical Device Wholesale License is a legal approval required to sell or distribute medical devices in bulk to retailers, hospitals, or distributors.

It is regulated by the Central Drugs Standard Control Organization under Medical Device Rules, 2017.

👉 Simple meaning:
If you want to deal in wholesale medical devices, you must have this license.

Who Needs Medical Device Wholesale License?

You must apply if you are:

• Medical device wholesaler

• Distributor

• Supplier to hospitals

• Importer of devices

• B2B medical equipment seller

📦Products Covered

This license covers devices like:

• BP monitors

• Thermometers

• Glucose meters

• Surgical instruments

• Diagnostic equipment

Medical Device Wholesale License Registration Process

1️⃣ Register on Portal

Create account on CDSCO SUGAM portal.

2️⃣ Fill Application Form

Submit application with required details.

3️⃣ Upload Documents

Attach all documents properly.

4️⃣ Inspection

Authorities may inspect storage and premises.

5️⃣ Approval

License is issued after verification.

📂 Documents Required

• PAN Card

• Aadhaar Card

• GST Certificate

• Premises proof

• Storage facility details

• Technical staff qualification

• Authorization letter

• Product list

Medical Device License Fees

Fees depend on:

• Business type

• Number of products

• State authority

👉 Approx range: ₹5,000 – ₹20,000

Timeline

• Processing: 10–20 days

• Approval: 20–30 days

👉 Total: 30–45 days

Common Mistakes

• ❌ Wrong application

• ❌ Incomplete documents

• ❌ No storage setup

• ❌ No qualified staff

Benefits

• Legal business operations

• Increased trust

• Business expansion

• Market credibility

Location Coverage

Applicable across India including:

• New Delhi

• Noida

How PSR Compliance Helps

• Documentation support

• Application filing

• Fast approval

• Expert consultation

FAQs

1. What is Medical Device Wholesale License?

It is a license to sell medical devices in bulk.

2. Is it mandatory?

Yes, it is required for wholesale business.

3. How to apply online?

Through CDSCO SUGAM portal.

4. What are fees?

₹5,000 – ₹20,000 approx.

5. Who issues license?

Authorities under the Central Drugs Standard Control Organization.

6. How long does it take?

30–45 days.

7. What documents required?

PAN, GST, premises proof, etc.

8. Can I sell without license?

No, it is illegal.

9. What is validity?

Usually 5 years.

10. Who needs this license?

Distributors, wholesalers, importers.

Contact Us

📞 Phone:+91 7065883416 

 📧 Email:[support@psrcompliance.com]
🌐 Website:https://www.psrcompliance.com/

 📍 Office Address: [D -49 , D block, Sector 6 , Noida , Uttar Pradesh, 201301]