What is a Medical Device Wholesale License?

A Medical Device Wholesale License is required for any individual or business engaged in the sale, stocking, exhibiting, or distribution of medical devices classified under Class A and Class B. The license is issued by the State Licensing Authority (SLA) under the supervision of the Central Drugs Standard Control Organization (CDSCO).

This license is not just a regulatory formality—it is a legal necessity to ensure only quality-assured medical devices are circulated in the Indian market.

Why You Need an MD-42 License

If your business deals with Class A or B medical devices, having a valid MD-42 license is essential. Here's why:

✅ It allows you to legally sell or distribute medical devices in India.

✅ Required for participating in government tenders and B2B transactions.

✅ Enhances trust and credibility with suppliers, hospitals, and end customers.

✅ Helps maintain compliance with Indian medical device regulations.

Agile Regulatory assists businesses at every stage—from document preparation to coordination with regulatory authorities—making the entire process hassle-free.

Who Should Apply?

The following entities should apply for a Medical Device Wholesale License:

Wholesalers of medical equipment

Distributors and stockists

E-commerce sellers of medical devices

Hospitals procuring devices for in-house use

Importers distributing devices in India

Startups entering the healthcare distribution space

Whether you're starting a new venture or expanding an existing business, Agile Regulatory provides tailored guidance to suit your business model.

Categories of Medical Devices Covered

CDSCO classifies devices into four categories based on risk:

ClassRisk LevelExamplesALow RiskBandages, thermometers, surgical glovesBLow to ModerateBlood pressure monitors, ECG machinesCModerate to HighInfusion pumps, diagnostic imaging toolsDHigh RiskCardiac stents, ventilators

The MD-42 license applies only to Class A and Class B medical devices. Distribution of higher-risk categories requires separate authorizations.

Prerequisites for License Application

To apply for a Medical Device Wholesale License, the following conditions must be met:

1. Qualified Technical Person

A person-in-charge must supervise your operations. The individual should meet one of the following:

Hold a degree in Pharmacy

Be a registered Pharmacist

Be a graduate with at least 1 year of experience in drug/medical device sales

2. Registered Premises

You need a suitable premise for storage and sale, which includes:

Sufficient area and hygiene

Secure storage facilities

Cold storage (if temperature-sensitive devices are involved)

Agile Regulatory helps assess and prepare your premises in accordance with CDSCO guidelines.

Documents Required

Here is a checklist of documents necessary for MD-42 license application:

Business Documents

Company Incorporation Certificate

GST Registration

PAN Card

Rent agreement or ownership proof of premises

Site layout with dimensions

Staff Documents

Qualification and experience certificate of the technical person

Photo ID and address proof

Passport-size photograph

Other Documents

List of medical devices to be distributed

Authorization letter (if applicable)

Our team ensures that all documents are verified and formatted correctly to avoid any delays in approval.

Step-by-Step Process with Agile Regulatory

We simplify the licensing process with a structured and efficient approach:

Step 1: Consultation

Our team connects with you to understand your business, products, and licensing requirements.

Step 2: Documentation

We assist in collecting, reviewing, and formatting all required documents, including floor plans, qualifications, and business registrations.

Step 3: Application Submission

We file the application online on the SUGAM portal and pay the government fees on your behalf.

Step 4: Coordination with Authorities

If the SLA requests additional information or conducts an inspection, we represent your case and manage communication.

Step 5: License Grant

Once all conditions are met, the State Licensing Authority issues the Form MD-42 license.

With Agile Regulatory, the entire process typically takes 4–6 weeks, depending on state-specific processing times.

Government Fees

Here are the standard fees for MD-42 license:

Application Fee: ₹3,000 per license

Inspection Fee (if applicable): ₹500

We offer competitive service packages that include full documentation, portal filing, coordination, and post-license support.

License Validity

Unlike some licenses that require annual renewal, the MD-42 license remains valid as long as there are no changes in your operations. However, in the event of:

Change in technical person

Relocation of premises

Addition of new device categories

…you must notify the authority and update your license accordingly. Agile Regulatory offers support for all such modifications.

Why Choose Agile Regulatory?

We bring deep expertise and personalized service to every case. Here's why businesses across India trust us:

✅ 5+ years of experience in medical device licensing

✅ Complete documentation support

✅ Fast turnaround and follow-up with SLA

✅ PAN India coverage

✅ Transparent pricing and no hidden charges

✅ Dedicated relationship manager for each client

Whether you're applying for your first license or scaling operations, we ensure a smooth journey from start to finish.

Additional Services We Offer

Agile Regulatory is a one-stop solution for regulatory needs. In addition to the Medical Device Wholesale License, we also assist with:

Medical Device Manufacturing License (MD-9/MD-10)

CDSCO Registration

BIS Certification for medical equipment

WPC, BEE, and LMPC certification

FSSAI and drug licenses

EPR registration for battery and plastic waste

Our integrated services help you launch and operate in full compliance with Indian regulations.

FAQs

Q1. Can I apply without a pharmacy degree?
Yes. A science graduate with one year of experience in sales of medical devices or drugs is also eligible.

Q2. Is a physical inspection mandatory?
Not always. Some state authorities may issue the license after document verification, while others may inspect the premises.

Q3. Can I use the same license for multiple locations?
No. Each location must have its own MD-42 license.

Q4. How long does it take to get the license?
Typically 30–45 working days, depending on your location and the SLA’s processing time.