MD 42 Wholesale License for Medical Devices in India

India’s healthcare and medical device market is growing rapidly but with that growth comes strict regulatory compliance.

If you are a distributor, wholesaler, stockist, importer, or e-commerce seller of medical devices (including IVDs), you must obtain an MD-42 License from the State Licensing Authority.

Without this license, even storing or selling medical devices is illegal and can result in penalties, product seizures, and loss of reputation.

MD-41 vs MD-42: What’s the Difference?

 In simple words: MD-41 = Application | MD-42 = License

Why Do You Need an MD-42 License?

•  Comply with CDSCO & Medical Device Rules
•  Ensure public health and product safety
• Meet quality standards (ISO 13485, GSDP)
• Build market trust (hospitals, e-commerce platforms demand MD-42)
• Enable business growth & expansion
• Avoid penalties, seizures, and notices

Who Needs an MD-42 License?

• Medical device wholesalers / stockists / distributors
• Importers storing devices before sale
• E-commerce sellers (Amazon, Flipkart, etc.)
• Any entity selling or distributing notified medical devices in India

Eligibility Criteria

To apply for an MD-42 License, you must:

1. Be a registered Indian business (Proprietorship / Partnership / LLP / Pvt. Ltd.)
2. Have a compliant storage facility (temperature-controlled, clean, secure)
3. Appoint a Competent Technical Staff (CTS):
• Pharmacist, OR
• Graduate, OR
• 12th pass with 1-year experience in medical device sales
4. Hold a manufacturer authorization letter (if you’re not the manufacturer)

Documents Required

• Duly filled MD-41 application
• Business cover letter
• Site / floor plan of storage premises
• Rent agreement or property proof
• GST / business registration certificates
• Educational qualifications & experience proof of Technical Staff
• Self-declaration of compliance
• Storage facility details (refrigeration, GSDP compliance)

MD-42 Application Process

Step 1: Fill & submit Form MD-41 via the CDSCO SUGAM portal / State FDA
Step 2: Upload all required documents
Step 3: Pay government fee (₹3,000)
Step 4: Site inspection / document verification by Drug Inspector
Step 5: Receive MD-42 License (valid for 5 years)

License Conditions (After Grant)

• Display the license at a visible location
• Maintain proper storage temperature & lighting
• Keep purchase/sales records for minimum 2 years
• Buy devices only from licensed suppliers
• Maintain Form MD-43 inspection book 

Why Choose ZYPS for MD-42 Licensing?

• Decades of regulatory experience
• 100% approval track record for MD-41 / MD-42 applications
• End-to-end support: documentation, portal filing, inspection coordination
• Based in New Delhi for faster regulatory liaison
• Trusted by leading manufacturers & distributors in India 

 Get Expert Help Today 

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