What is a Medical Device Wholesale License?
A Medical Device Wholesale License is an official permission granted by the State Licensing Authority under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. It allows an individual or business entity to legally sell or distribute notified medical devices to retailers, hospitals, and healthcare institutions.
This license is issued in Form MD-42 for wholesale purposes and ensures that only authorized and qualified persons handle the sale and distribution of medical devices in India.
Who Needs This License?
If your business involves the sale, stock, exhibit, or distribution of notified medical devices, you are required to obtain the Medical Device Wholesale License. This includes:
- Wholesalers or distributors
- Importers intending to sell within India
- Online platforms selling medical equipment
- Businesses supplying to hospitals and clinics
- Medical device marketing or logistics firms
This license is mandatory for companies dealing in Class A and Class B medical devices. For Class C and D devices (which are high-risk), additional regulatory steps may be required.
Classification of Medical Devices
Under the CDSCO’s risk-based classification system:
- Class A – Low-risk devices (e.g., thermometers, tongue depressors)
- Class B – Moderate-risk devices (e.g., surgical masks, IV sets)
- Class C & D – High-risk devices (e.g., dialysis machines, heart valves)
The Medical Device Wholesale License generally covers Class A and B devices.
Benefits of Having a Medical Device Wholesale License
- ✅ Legal Authorization to Distribute Devices
- ✅ Boosts Market Credibility & Trust
- ✅ Enables Supply to Hospitals, Clinics, and Government Tenders
- ✅ Ensures Compliance with CDSCO Norms
- ✅ Allows You to Expand Operations Across India
How Agile Regulatory Helps You
At Agile Regulatory, we offer complete assistance in obtaining the Medical Device Wholesale License under Form MD-42. We simplify the entire process—from application to approval—saving you time, effort, and uncertainty.
Here’s how we support you:
1. Initial Consultation & Eligibility Check
We start by understanding your business setup, products, and storage premises. Based on this, we identify the correct license category and guide you accordingly.
2. Document Preparation
Our team compiles all required documents, checks their accuracy, and ensures they meet the CDSCO’s format and guidelines.
3. Application Filing on SUGAM Portal
We handle your online application submission through the CDSCO’s SUGAM portal, avoiding common errors that could delay approval.
4. Inspection Preparation
We help you get your premises ready for inspection—this includes cold storage verification (if required), documentation setup, and technical requirements.
5. Follow-ups with Licensing Authority
We stay in constant touch with state licensing officers to ensure your file moves forward quickly.
6. Post-License Support
After you receive your MD-42 license, we assist you with compliance, record-keeping, and future renewals.
Documents Required for Medical Device Wholesale License
To apply for the MD-42 license, the following documents are needed:
- Duly filled Form MD-42 application
- Covering letter with business details
- Copy of business registration (Company/LLP/Proprietorship)
- GST certificate
- Premises ownership proof or rent agreement
- Layout plan of storage area
- Details of refrigerator or cold chain equipment (if needed)
- Educational qualification and experience certificate of the competent person (e.g., Pharmacist or Science Graduate with experience)
- List of medical devices to be distributed
- Declaration of compliance with the Medical Device Rules
Agile Regulatory ensures your documentation is complete, accurate, and ready for submission.
Government Fees for MD-42 License
- Application Fee: ₹3,000
- Inspection Fee: ₹500 (if applicable)
Note: Fees are subject to change as per state or central government norms.
Processing Time
The average timeline for receiving the MD-42 license is 30–45 working days, depending on:
- Accuracy of documentation
- State-wise processing speed
- Completion of inspection
We aim to minimize delays by proactively coordinating with the regulatory authorities.
Storage & Infrastructure Requirements
To obtain a Medical Device Wholesale License, your premises must meet specific conditions:
- Adequate storage space with proper lighting and ventilation
- Cold storage or refrigeration units if required for specific devices
- Separate area for quarantine or expired goods (if applicable)
- Secure locking systems and proper labeling
- Availability of a qualified person at the premises
Agile Regulatory provides detailed guidance on setting up your facility according to CDSCO norms.
Validity & Renewal
Unlike older drug licenses, the MD-42 license is valid perpetually, provided the licensee:
- Pays the retention fee every 5 years
- Maintains proper sale and purchase records
- Adheres to storage and personnel conditions
We also provide license renewal reminders and annual compliance assistance.
Why Choose Agile Regulatory?
Here’s what sets us apart:
- 🏆 Experienced Consultants: 10+ years of expertise in regulatory filings
- 🌐 Pan-India Services: Serving clients in all major states
- 📋 Zero Error Documentation: Checked and verified before submission
- 📞 Ongoing Support: From initial consultation to license renewal
- 💼 Custom Solutions: For startups, importers, e-commerce platforms, and more
We’re more than just consultants—we’re your partners in regulatory success.
Ready to Apply for Your License?
Whether you’re launching a new medical device distribution business or expanding your existing operations, getting the right license is the first step.
With Agile Regulatory, you don’t need to worry about technicalities, delays, or rejections. Our team takes care of everything so you can focus on your core business.
