MD42 License

Tue, Jan 27 2026

Raju Karn

MD-42 License for Importers in Delhi NCR: Step-by-Step Process (2026 Updated)

If you import medical devices into India and sell them in Delhi NCR, you must have an MD-42 License.
Without this license, importing or selling medical devices—even small items—can lead to seizure, penalties, and legal action.

This guide explains the MD-42 license for importers in very simple words, step by step, so even a first-time importer can understand it easily.

What is an MD-42 License?

An MD-42 License is a registration certificate issued by the State Licensing Authority (SLA) under the CDSCO (Central Drugs Standard Control Organization).

It allows businesses to:

Import medical devices
Stock medical devices
Distribute and sell medical devices in India

The application is filed online through the ONDLS CDSCO portal.

Who Needs an MD-42 License in Delhi NCR?

You need an MD-42 License if you are:

➜ An importer of medical devices

➜ A distributor or wholesaler

➜ A retailer selling imported medical devices

➜ An e-commerce seller of medical devices

➜ A company stocking devices in a warehouse or godown

📌 Each physical location needs a separate MD-42 license.

Medical Devices Covered Under MD-42

MD-42 applies to notified medical devices, including:

➤ Diagnostic devices

➤ Surgical instruments

➤ Hearing aids

➤ Orthopedic devices

➤ Medical implants

➤ Monitoring equipment

➤ Imported consumables and accessories

Even low-risk devices now fall under CDSCO regulation.

Advantages of MD-42 License for Importers

↔ Legal right to import medical devices

↔ Smooth customs clearance

↔ Eligibility to sell on Amazon, Flipkart & B2B portals

↔ Builds trust with hospitals & distributors

↔ Avoids penalties and business disruption

↔ Required for long-term compliance in India

Step-by-Step Process to Apply for MD-42 License (2026)

Step 1: Create Login on ONDLS CDSCO Portal

Visit the CDSCO online portal
Register your firm using email and mobile number
Choose “Medical Device Registration”

Step 2: Prepare Required Documents

All documents must be clear, updated, and signed.

Step 3: File Form MD-41 Online

MD-41 is the application form
Fill importer details, device category, and premises details
Upload documents
Pay government fees online

Step 4: Premises Verification

Authority may verify:

Storage area
Temperature control
Cleanliness
Record-keeping system

Step 5: Grant of MD-42 License

After approval, MD-42 License is issued online

You can download it from the CDSCO license download section

Documents Required for MD-42 License

You will need:

→ Importer company PAN & GST

→ Address proof of premises

→ Rent agreement / ownership proof

→ Site layout plan

→ List of medical devices imported

→ Authorization letter from manufacturer

→ Quality system declaration

→ ID & address proof of applicant

→ Undertaking for compliance

📌 Documents must match portal details exactly to avoid rejection.

Premises Requirements for Importers

▪ Clean and dedicated storage area

▪ Proper ventilation

▪ Protection from dust & moisture

▪ Separate area for damaged/returned devices

▪ Temperature control if required

No retail counter is mandatory for import-only operations.

How Long Does MD-42 Approval Take?

Normal timeline: 20–40 working days

Delays happen due to:

⁃ Wrong documents

⁃ Incorrect device classification

⁃ Portal mistakes

Validity of MD-42 License

MD-42 license is valid indefinitely
Retention fee must be paid every 5 years
Non-payment may lead to cancellation

Penalties for Operating Without MD-42 License

Selling or importing without MD-42 can lead to:

‣ Stock seizure

‣ Penalty up to ₹5–10 lakh

‣ Business closure

‣ Legal prosecution under Medical Device Rules

Common Reasons for MD-42 Rejection

⚠ Wrong device category

⚠ Mismatch in address documents

⚠ Incomplete authorization letters

⚠ Uploading expired certificates

⚠ Filing without understanding CDSCO rules

⚠This is where professional help matters.

Need help with your MD-42 license?
Talk to PSR Compliance and get clear guidance without confusion.
📞 Call 7065883416

Frequently Asked Questions (FAQs)

1. What is the difference between MD-41 and MD-42?
MD-41 is the application form submitted by the importer or distributor, while MD-42 is the license issued by the Authority allowing sale and distribution of medical devices.

2. Is MD-42 mandatory for all medical device importers?
Yes, any importer or distributor storing and selling medical devices must obtain an MD-42 license under the Medical Devices Rules, 2017.

3. What documents are required for an MD-42 license?
PAN/Aadhaar, GST or company registration, premises proof, technical staff qualification documents, and GDP compliance self-certification.

4. What is the validity of the MD-42 license?
The MD-42 license is valid for a lifetime, subject to payment of a ₹3,000 retention fee every five years.

5. Is inspection required for MD-42 approval?
Yes, the State Licensing Authority may inspect the premises to verify storage conditions and staff qualifications.

6. What are the penalties for operating without an MD-42 license?
Importing or selling without an MD-42 license can result in penalties, product seizure, and legal action.

7. Do e-commerce sellers need an MD-42 license?
Yes, online platforms require a valid MD-42 license to list and sell medical devices.