MD 41 and MD 42 License in India: Requirements, Process & Compliance

  • MD 41 and MD 42 License governs the wholesale distribution of medical devices in India, ensuring compliant storage, tracing, and supply chain integrity.
  • MD 41 MD 41 is the application submitted for obtaining a wholesale medical device license.
  • MD 42 is the approved wholesale license issued by the State Licensing Authority.
  • Mandatory for all device classes: A, B, C, and D.
  • Essential for distributors, importers, traders, and hospital suppliers.
  • Ensures compliance with India’s Medical Devices Rules, 2017.

Introduction

In early 2024, one of our clients from Pune, a newly established medical equipment trading firm, contacted Silvereye Certifications last year with a common problem: They had stocked imported pulse oximeters and diagnostic devices worth over 40 lakhs, but their shipments were held during inspection because they did not possess the required MD 41 and MD 42 License.

Their accountant had assumed that a basic drug wholesale license was enough. But medical devices in India no longer fall under the traditional Drugs & Cosmetics Act alone. Once the Medical Device Rules, 2017 (MDR 2017) came into effect, the landscape changed.

This situation is now extremely common. Every month, we receive queries from distributors, importers, and hospital suppliers unsure whether they need an MD 41 License, an MD 42 License, or both.

What is an MD 41 & MD 42 License?

The MD 41 & MD 42 License refers to the regulatory approval required for businesses involved in the wholesale distribution, stocking, or sale of notified medical devices in India.

What is MD 41 and MD 42 License?

The Medical Devices Rules, 2017, introduced a structured regulatory system for selling, stocking, exhibiting, or distributing medical devices in India. Under these rules, the government created two key authorizations for wholesale operations, established through Rule 87A.

Parameter MD 41 (Form) MD 42 (Certificate)
Type Application Form (Submitted by applicant) Final Wholesale License (Issued by SLA)
Purpose To apply for permission to sell, stock, or distribute medical devices. Official approval to legally wholesale medical devices.
Status Initiates the licensing process. Confirms business meets MDR 2017 standards.
Legal Function Allows authority to evaluate premises, staff, and documentation. Grants legal authorization to conduct wholesale business.

The MD 42 License is the final approval document that legally authorizes a firm to sell, stock, exhibit, offer for sale, or distribute medical devices and in-vitro diagnostic devices in India.

Why the MD 41 and MD 42 License Matters for Indian Businesses?

Benefit Category Description
Legal Compliance Ensures the business operates legally under the Medical Devices Rules, 2017, preventing violations during inspections.
Risk Mitigation Protects businesses from shipment seizure, penalties, or operational shutdown during audits.
Tender Eligibility Mandatory qualification for vendors participating in government and corporate healthcare tenders (GeM listings).
Market Credibility Builds trust with hospitals, diagnostic chains, and corporate healthcare clients who prefer licensed distributors.
Quality Assurance Ensures devices are stored, handled, and distributed by trained and authorized personnel under proper standards.
Traceability Helps importers and large distributors maintain essential traceability and accountability required by CDSCO.

MD 41 and MD 42 License in India: Requirements, Process & Compliance

  • MD 41 and MD 42 License governs the wholesale distribution of medical devices in India, ensuring compliant storage, tracing, and supply chain integrity.
  • MD 41 is the application submitted for obtaining a wholesale medical device license.
  • MD 42 is the approved wholesale license issued by the State Licensing Authority.
  • Mandatory for all device classes: A, B, C, and D.
  • Essential for distributors, importers, traders, and hospital suppliers.
  • Ensures compliance with India’s Medical Devices Rules, 2017.

Understanding the Classification Before Applying (MD-41)

Before applying for a wholesale medical device license, you must correctly classify the devices you handle, as this impacts premises and staff requirements.

Class Risk Level Wholesale Handling Requirement
Class A Low Risk (e.g., Bandages, Stethoscopes) Must be listed in the MD-41 application.
Class B Low to Moderate Risk (e.g., BP Monitors, Nebulizers) Must be listed in the MD-41 application
Class C Moderate to High Risk (e.g., Ventilators, Ultrasound Systems) Still requires MD-41 application, demanding higher scrutiny of storage.
Class D High Risk / Life-supporting Devices (e.g., Implants, Defibrillators) Still requires MD-41 application, requiring stringent handling protocols.

Why classification matters: Authorities verify whether your infrastructure and technical staff qualifications match the risk class of the devices listed in your MD-41 application.

Who Actually Needs an MD 41 or MD 42 Wholesale License?

You need this license if your business performs the wholesale function of:

  • A trader sourcing medical devices from manufacturers.
  • A distributor supplying hospitals, retail stores, or diagnostic chains.
  • An importer storing devices before distribution.
  • A supplier for government or institutional tenders.
  • An online seller dealing in regulated medical devices.

Benefits of MD 41 and MD 42 License

Benefit Category Benefit Description for MD 41 & MD 42 License
Legal Compliance Ensures the business operates legally under the Medical Devices Rules, 2017.
Regulatory Approval Grants government authorization to sell, stock, and distribute medical devices.
Market Credibility Builds trust with hospitals, diagnostic centres, importers, and tender authorities.
Smooth Supply Chain Prevents stock seizure, compliance delays, or penalties during inspections.
Tender Eligibility Mandatory for participation in government and corporate healthcare tenders.
Quality Assurance Ensures devices are stored, handled, and distributed under proper standards.

Documents Required for MD 41 and MD 42 License

Although state-wise requirements may slightly differ, the core documentation for Form MD-41 includes:

  • Applicant & Business Documents: Constitution of firm (Partnership/LLP/Pvt Ltd), GST certificate, PAN, Identity/address proof of owners.
  • Premises Documents: Layout plan with dimensions, ownership/rent agreement, storage infrastructure details, and photographs.
  • Competent Technical Staff (CTS) Documents: Qualification certificates, experience proof, appointment letter, and salary records.
    • CTS Qualification: Must be a Science Graduate, Registered Pharmacist, or Intermediate-passed with 1+ year of relevant experience.
  • Device-Specific Documents: List of medical devices, classification details, and purchase/authorization letters (if needed).
  • Record Maintenance: SOPs for storage, handling, complaints, recall, and compliance with Good Distribution Practices (GDP).

MD 41 and MD 42 License Application Process Explained Step-by-Step

  • Product Classification & Premises Preparation: Accurately classify all devices (A/B/C/D) and ensure the storage facility meets fire safety, segregation, and temperature control norms.
  • Document Compilation: Gather and verify all business, premise, CTS, and device-specific documents.
  • Online Application Submission: Register on the CDSCO SUGAM portal and submit Form MD-41 with all supporting documents.
  • Fee Payment: Pay the prescribed application fee (currently ₹3,000 INR).
  • Inspection by Drug Control Department: A government Drug Inspector visits the premises to verify storage, temperature logs, device segregation, CTS presence, and documentation.
  • License Approval: Upon successful evaluation and query resolution, the license is granted in Form MD-42 and uploaded digitally.
  • Post-License Compliance: Maintain continuous records, adherence to GDP, and pay retention fees.

MD 41 & MD 42 License – Timeline, Cost, Validity & Renewal

Parameter Detail
Application Fee ₹3,000 INR (Government Fee)
Typical Timeline 30–90 days (Varies by State Licensing Authority).
Validity Perpetual / Indefinite
Renewal / Retention Mandatory payment of a Retention Fee (currently ₹3,000 INR) every five years.

Why Silvereye Certifications Is the Best Consultant for MD 41 and MD 42 License

  • Error-free submission process, ensuring that Form MD-41 is filed correctly with all supporting documents and compliance proofs.
  • Premises assessment and improvement guidance to help businesses meet warehouse and storage standards required for wholesale medical device operations.
  • Dedicated regulatory managers who monitor the entire process and provide real-time updates until the MD-42 License is issued.
  • Proven track record of securing Wholesale Medical Device Licenses for distributors, importers, traders, hospital suppliers, and startups across India.
  • Post-license compliance support, helping companies maintain logs, records, complaint registers, and retention requirements under MDR 2017.

Conclusion

Wholesale distribution of medical devices requires structured compliance, and the MD 41 and MD 42 License form the backbone of legal operations in India. Whether a business handles simple diagnostic tools or advanced therapeutic equipment, choosing the correct license ensures uninterrupted supply, regulatory protection, and trust with customers. Don't let a compliance gap seize your inventory.

Silvereye Certifications supports manufacturers, traders, importers, and hospital suppliers with complete end-to-end guidance so they can operate confidently and compliantly under the Medical Devices Rules, 2017.

FAQs on MD 41 and MD 42 License

MD 41 is the application form submitted to the State Licensing Authority to request approval for wholesale distribution of medical devices under MDR 2017.

MD 42 is the final wholesale license issued after MD 41 is approved. It authorises a business to sell, stock, and distribute medical devices legally.

Any distributor, trader, importer, hospital supplier, or online seller dealing in medical devices must obtain the MD 42 wholesale license.

Yes. Businesses handling Class A, B, C, or D medical devices must apply via MD 41 and receive approval through MD 42.

Yes, every applicant must appoint qualified technical staff responsible for compliance and storage oversight.

Most approvals take 30–90 days, depending on documentation quality and inspection timelines.

It remains valid indefinitely with timely payment of retention fees and continued compliance.

Authorities may seize stock, impose penalties, or restrict the business during audits and tenders.

Yes, MD 42 can include Class A, B, C, and D devices if the premises and CTS meet requirements.

Silvereye Certifications provides complete support—from documentation and classification to inspection preparation—making the MD 41 and MD 42 license process faster, accurate, and compliant.

At Silvereye Certifications & Consulting Services Pvt. Ltd., we simplify compliance and certification processes, guiding you to achieve and maintain required industry approvals with complete trust.

silvereye certification linkdin silvereye certifications instagram icon icon icon icon
Subscribe to be in touch with latest news.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Support
Privacy Policy Refund Policy
Services
Company Registration
Product Compliance
Waste Management
Import and Export
Product Testing
Contact Info
Ground floor, C-116, C Block, Sector 2,
Noida, Uttar Pradesh 201301+91-9625369071 contact@seyecs.com

IMPORTANT DISCLAIMER: Silvereye Certifications is a private consulting firm. We do NOT issue government certificates, licenses, or official documents. We provide professional consulting services to help businesses navigate the application process for government certifications. All certificates and approvals are issued solely by the relevant government authorities.

Copyright © 2024 Silvereye Certifications & Consulting Services Pvt. Ltd. All Rights Reserved.