Medical Device Wholesale License – Simplified with Agile Regulatory

What is a Medical Device Wholesale License?
A Medical Device Wholesale License authorizes a business to sell, stock, exhibit, or distribute medical devices in India. It is issued under Form MD-42 by the State Licensing Authority (SLA), as per the Medical Devices Rules, 2017, which were framed under the Drugs and Cosmetics Act, 1940.

This license is specifically applicable to distributors or wholesalers dealing in Class A and Class B medical devices, which are categorized based on the risk level of the device.

Who Needs the License?
You need an MD-42 license if you are:

A wholesaler or distributor of medical devices

An e-commerce seller dealing in regulated medical equipment

A business supplying to hospitals, clinics, or government health programs

An importer looking to distribute medical devices within India

It’s important to remember that selling medical devices without this license is a legal offense and can lead to penalties or cancellation of operations.

Medical Device Classification in India
India classifies medical devices into four categories based on risk:

Class Risk Level Examples
A Low Surgical dressings, thermometers
B Low to Moderate Nebulizers, BP monitors, syringes
C Moderate to High Dialysis machines, anesthesia systems
D High Heart valves, pacemakers
MD-42 is required only for Class A & B devices. For Class C & D, a manufacturing or import license (Form MD-43) is needed.

Benefits of Getting Licensed with Agile Regulatory
Obtaining a Medical Device Wholesale License involves technical knowledge, documentation, and communication with the drug authorities. That’s where Agile Regulatory comes in.

Here’s how we make it easy:

✅ Expert consultation: We assess your product category and eligibility

✅ Documentation support: We help prepare all required paperwork accurately

✅ Online portal registration: We handle CDSCO’s SUGAM portal submission

✅ Inspection assistance: We prepare your site for a successful inspection

✅ End-to-end coordination: From application to license grant, we handle it all

We’ve helped distributors across India get their MD-42 license quickly—with minimal hassle.

Requirements for MD-42 License
To apply for the Medical Device Wholesale License, certain infrastructure and personnel qualifications are mandatory.

1. Infrastructure Requirements: Premises with adequate space and cleanliness

Proper ventilation and storage racks

Cold storage facility (if applicable)

Fire safety measures

1. Competent Person: The applicant must appoint a competent technical person who:

Has a degree in pharmacy or science

Has at least 1 year of experience in the sale of medical devices or pharmaceuticals

Agile Regulatory helps verify and arrange the required qualifications and documentation for your technical staff.

Documents Required
Here’s a checklist of documents you'll need to apply for the MD-42 license:

For Business Entity:
Company registration certificate (Proprietorship, Partnership, LLP, or Pvt Ltd)

PAN card and GST certificate

Address proof of the business premises

For Competent Person:
Educational qualification (Pharmacy/Science graduate)

Experience certificate

ID and address proof

Appointment letter

Other Documents:
Site plan/layout of the premises

Rent agreement/ownership proof of premises

Product list with classification

Authorization letter from the manufacturer (if distributing third-party products)

Agile Regulatory ensures all documents are compiled and formatted as per the requirements of the Licensing Authority.

Step-by-Step Process – How Agile Regulatory Helps
Our simplified process ensures a smooth experience:

Step 1: Consultation
We assess your business model, product type, and compliance readiness.

Step 2: Documentation
Our team collects and prepares all documents, checking for accuracy and completeness.

Step 3: CDSCO Portal Registration
We register your business on the SUGAM Portal and initiate the MD-42 application.

Step 4: License Application Submission
We upload documents, fill required forms, and pay the government fees.

Step 5: Premises Inspection
The Drug Inspector may inspect your site. We guide you on infrastructure and documentation to ensure you pass this stage.

Step 6: License Grant
Once approved, the license is issued under Form MD-42. It remains valid perpetually, subject to payment of retention fees every 5 years.

Government Fees
The official government fee for MD-42 license application is:

₹3,000 for the license

₹500 inspection fee (if applicable)

Agile Regulatory charges a transparent professional fee based on the scope and location. Contact us directly for a customized quote.

Timeline
On average, the MD-42 license can be obtained within 30 to 45 working days, assuming your premises and documents are in order.

Agile Regulatory speeds up the process by reducing chances of rejection and ensuring timely follow-ups with the licensing authority.

Post-License Compliance
Once the license is issued, you must:

Maintain proper records of sales and purchases

Store products according to prescribed conditions

Renew staff qualifications or infrastructure changes as needed

Inform the authority about any changes in business structure or address

We offer compliance support services to help you maintain your license without hassle.

Why Choose Agile Regulatory?
🎯 5+ years of industry experience

🔍 100% documentation accuracy

📞 Dedicated support from start to finish

💼 Servicing clients across India

📄 Assistance with product classification, CDSCO queries, and more

We don’t just help you get the license—we become your long-term compliance partner in the healthcare sector.

Let’s Get Your MD-42 License – Fast and Easy
Whether you're a startup entering the medical device supply chain or an established distributor expanding to new product lines, Agile Regulatory is here to make your licensing journey seamless.

Let us handle the paperwork while you focus on growing your business.