What is a Medical Device Wholesale License?
The Medical Device Wholesale License (MD-42) is a mandatory certificate issued under the Medical Devices Rules, 2017. It allows businesses to stock, sell, exhibit, or distribute Class A and Class B medical devices in India.
Issued by the State Licensing Authority (SLA), this license is critical to ensure that only safe and compliant medical devices are introduced into the Indian market. Without this license, dealing in medical devices is a legal violation that may lead to penalties or closure of the business.
Who Needs the MD-42 License?
You need this license if you are involved in:
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Wholesale or distribution of medical devices
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Operating a medical device warehouse or stockist unit
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Running an online store selling medical devices
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Importing medical devices and reselling in India
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Hospitals or institutions buying for internal distribution
Whether you’re an established business or an aspiring startup, if you're handling medical devices commercially, you must obtain this license.
Medical Device Classification: Class A & B
Under CDSCO’s classification:
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Class A (Low Risk): Bandages, surgical gloves, digital thermometers, etc.
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Class B (Low-Medium Risk): BP monitors, ECG machines, nebulizers, etc.
The MD-42 license specifically permits wholesale dealing in these two categories. For higher-risk devices (Class C & D), different approvals are required.
Eligibility Criteria for MD-42 License
To apply for a Medical Device Wholesale License, your business must meet the following requirements:
1. Premises
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Should be hygienic, well-ventilated, and legally occupied.
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Must include adequate space for storage, especially for temperature-sensitive devices.
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Cold storage facilities, if applicable.
2. Technical Staff
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Must appoint a competent person to supervise sales and storage.
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Eligibility of the technical person:
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Registered pharmacist, or
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Graduate with minimum 1 year experience in sales of medical devices or drugs
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Agile Regulatory can help you assess your team and premises to ensure full compliance before application submission.
Required Documents
Here’s a list of documents required for applying for the MD-42 license:
Business Documents:
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Company PAN card
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Certificate of Incorporation or business registration
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GST registration certificate
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Rent agreement or property ownership proof
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Site plan of premises
Technical Staff Documents:
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Qualification certificate
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Experience letter (if required)
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Aadhaar and PAN Card
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Passport-size photograph
Other:
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List of medical devices to be sold
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Cold storage details (if applicable)
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Electricity and water bills for premises proof
Agile Regulatory’s documentation team ensures everything is organized, formatted, and submitted correctly, reducing the chance of delays or rejections.
Step-by-Step Process with Agile Regulatory
At Agile Regulatory, we follow a simplified, efficient, and transparent process:
Step 1: Free Consultation
Our experts understand your business model, product range, and location to guide you on the exact license requirements.
Step 2: Document Preparation
We assist in preparing and verifying all documents, including technical staff profiles, site layout, and device list.
Step 3: Online Application Filing
The license application is submitted through the SUGAM CDSCO portal, and government fees are paid.
Step 4: State Authority Coordination
We coordinate directly with the State Licensing Authority, respond to queries, and manage site inspections if required.
Step 5: License Issuance
Once approved, you receive the MD-42 license which permits you to begin wholesale activities.
Our end-to-end support ensures you don’t have to navigate regulatory complexities alone.
Government Fees for MD-42 License
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Application Fee: ₹3,000 per license
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Inspection Charges (if applicable): ₹500
Agile Regulatory’s consulting fee is affordable and covers the full scope of service—consultation, documentation, filing, and follow-up.
License Validity and Renewal
The MD-42 license remains valid perpetually, unless suspended, cancelled, or modified. However, if any changes occur—such as shifting of premises, change in technical person, or adding new device categories—you must notify the authority and amend the license.
Agile Regulatory helps with license amendments and post-license compliance as well.
Why Choose Agile Regulatory?
We’ve helped hundreds of businesses across India get licensed smoothly. Here's why we’re trusted:
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✅ 5+ years of experience in regulatory licensing
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✅ Fast and efficient processing
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✅ PAN-India coverage
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✅ Transparent pricing
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✅ Dedicated relationship managers
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✅ Post-licensing support for amendments and audits
Our team ensures that you stay compliant while focusing on growing your business.
Common Challenges We Solve
Applying for an MD-42 license may seem straightforward, but common issues arise, such as:
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Incorrect or incomplete documents
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Site plan not matching premises
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Lack of qualified staff
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Delays in SLA communication
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Portal errors or payment failures
We eliminate these hurdles with expert intervention, so you can get licensed without stress or confusion.
Additional Services We Offer
Apart from MD-42 licensing, Agile Regulatory also provides:
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MD-41 License (Retail of Medical Devices)
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Medical Device Manufacturing License (MD-5, MD-9, MD-10)
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CDSCO Import Registration
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BIS Certification for medical devices
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WPC, EPR, and BEE certifications
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Drug license (wholesale/retail)
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LMPC Certificate for importers
We’re a one-stop solution for all regulatory certifications in India’s medical and healthcare sector.
Frequently Asked Questions
Q. How long does it take to get the MD-42 license?
Typically, 3–5 weeks depending on your state and SLA’s responsiveness.
Q. Can I apply for multiple device types under one license?
Yes, if they all fall under Class A or B.
Q. Do I need to renew the license every year?
No. The license remains valid until changes are made or cancelled by authority.
Q. Can one technical person handle more than one location?
No. Each licensed premise requires a dedicated qualified person.
Q. What happens if I start operations without a license?
It is a legal offense and can attract heavy penalties and even closure.
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