Medical Device Wholesale License: Get Started with Agile Regulatory

What is a Medical Device Wholesale License?

The Medical Device Wholesale License allows businesses to sell, stock, exhibit, or offer for sale medical devices in India. As per the Medical Devices Rules, 2017, this license is required for Class A and Class B devices. These rules fall under the broader framework of the Drugs and Cosmetics Act, 1940, and the regulatory authority is the Central Drugs Standard Control Organization (CDSCO).

The license is issued in Form MD-42, following submission of the application in Form MD-41 to the State Licensing Authority (SLA).

Who Needs This License?

If your business is involved in any of the following activities, you must apply for a Medical Device Wholesale License:

Wholesale or distribution of medical devices
Supplying to hospitals, clinics, or retail pharmacies
Import and redistribution of Class A and B devices
E-commerce platforms dealing with medical equipment
Institutional suppliers or government contractors

Without the proper license, your operations could be considered unauthorized, which can lead to fines, shutdowns, or legal action.

Device Classification: What Falls Under Class A & B?

Understanding the classification of your products is the first step toward applying for the right license. The CDSCO classifies medical devices based on the risk they pose:

Class	Risk Level	Examples
A	Low	Surgical dressings, thermometers, wheelchairs
B	Low to Moderate	BP monitors, syringes, infusion pumps

Classes C and D involve higher-risk devices and require different types of licenses (like Form MD-43).

Key Requirements for Obtaining MD-42 License

Before you apply, ensure that your business meets the basic eligibility criteria:

1. Premises

Must have a clean, well-maintained storage area
Should include temperature control if applicable
Proper ventilation and fire safety precautions
Designated area for record keeping and packaging

2. Technical Staff

You must appoint a competent person to supervise the sale and distribution of devices:

A registered pharmacist, or
A person with a degree or diploma in Pharmacy or Science
Must have at least 1 year of experience in medical device or drug sales

Documents Required

Agile Regulatory provides complete documentation support. Here’s a list of the most commonly required documents:

Business Documents

Company registration certificate
GST certificate
PAN card
Address proof of premises (rent agreement/ownership deed)

Technical Staff Documents

Educational qualification certificate
Experience letter or appointment letter
Photo ID and address proof

Infrastructure Proof

Blueprint or layout of the premises
Equipment details (if cold chain or refrigeration is required)
Fire NOC (if needed)

Application Process Through Agile Regulatory

Here’s how we help you secure your MD-42 license:

Step 1: Expert Consultation

We assess your product list, confirm the classification, and identify if the MD-42 license is appropriate for your business model.

Step 2: Documentation

We collect, verify, and organize all required documents. If you need help with site layout, staff appointment letters, or declarations—we assist with those too.

Step 3: Application Filing

Your application is filed online through the SUGAM portal, where we handle the technical aspects, attachments, and final submission.

Step 4: Department Coordination

We coordinate directly with the State Licensing Authority, respond to queries, and schedule inspections if required.

Step 5: License Approval

Once approved, your Form MD-42 license is issued. This license is your legal permission to sell and distribute medical devices in India.

Government Fees

Application Fee (Form MD-41): ₹3,000
Inspection Fee (if applicable): ₹500

Note: These are standard CDSCO charges and do not include any consultancy or document preparation costs. Agile Regulatory offers affordable and transparent service packages.

Validity and Renewal

The MD-42 license has perpetual validity, meaning it remains valid unless canceled or suspended. However, you are required to:

Maintain proper records of sales and stock
Renew your business and drug license registrations (as applicable)
Ensure your premises and staff meet ongoing requirements

We also assist with license modifications, such as change in address, technical staff, or addition of new products.

Benefits of Working with Agile Regulatory

Agile Regulatory brings a professional, efficient approach to medical device licensing. Here's why hundreds of businesses trust us:

✅ Specialized experience in drug and device licensing
✅ End-to-end assistance, from documentation to inspection support
✅ PAN-India service coverage, across all states and UTs
✅ Fast processing with minimized delays and rejections
✅ Affordable pricing, no hidden costs

We act as your extended regulatory team so you can focus on business growth.

Post-License Services

Our support doesn’t stop once you get your license. We also offer:

Compliance audits and mock inspections
Renewal reminders and documentation help
License amendments (address, staff, products, etc.)
Additional licensing support (import license, manufacturing, retail, etc.)

Whether you're starting small or expanding nationwide, we stay with you at every stage.

Frequently Asked Questions (FAQs)

Q1: How long does it take to get an MD-42 license?
➡️ Generally, 4 to 6 weeks depending on document readiness and department workload.

Q2: Can I apply for both Class A & B products together?
➡️ Yes, one MD-42 license covers both Class A and Class B products.

Q3: Is physical inspection mandatory?
➡️ Not always, but some state authorities may conduct an inspection. We help you prepare.

Q4: Can an e-commerce business apply for MD-42?
➡️ Yes, provided they have a physical warehouse and comply with all storage and staff requirements.

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