MD 42 Medical Device Wholesale License : Process, Documents, Cost & Validity

• MD 42 License authorises wholesale storage and distribution of medical devices in India.
• Required for distributors, importers, stockists, B2B suppliers and warehouse-based healthcare supply businesses.
• It is mandatory for businesses dealing in Class A and Class B medical devices, ensuring regulatory compliance and traceability.
• Valid long-term under MDR 2017 with no annual renewal; retention fee must be paid every 5 years.
• Cost, validity, and documentation depend on scale of business, premises compliance, and authorised technical personnel.

Introduction

When distributors enter the medical device business for the first time, their biggest misconception is that a GST number and warehouse are enough to start supply. A real case from Pune in 2024 proves otherwise. A wholesale company supplying diagnostic kits to 40 hospitals received a compliance notice because they were operating without an MD 42 Wholesale License. Their stock was sealed and it took 6 weeks and financial losses to resume operations.

This is where organizations finally realize the difference between selling regular goods and handling medical devices. The business demands traceability, safety assurance, and regulatory accountability, and MD 42 stands at the center of it.

What is an MD 42 License?

An MD 42 License is the official certificate issued by the State Licensing Authority (SLA) under the Medical Devices Rules (MDR) 2017 that grants legal permission to a business to wholesale medical devices in India.

The wholesale activity involves storing and selling medical devices in bulk to hospitals, clinics, dealers, labs, government bodies, or other distributors.

• The application for this license is submitted through Form MD-41.
• The final approval certificate is issued in Form MD-42.
• The license is mandatory for businesses dealing in the wholesale supply of all medical device classes (A, B, C, and D).

Why is the MD 42 License important?

Medical devices directly impact patient safety. To make sure only safe and traceable products enter the healthcare market, the government requires wholesalers to meet proper:

• Storage conditions
• Documentation and inventory record-keeping
• Trained technical personnel handling medical devices

Without the MD 42 License, authorities can:

• Stop business operations
• Seal warehouse stocks
• Impose heavy penalties

So the license is not just a formality; it protects both patients and businesses.

Who needs the MD 42 License?

An MD 42 Wholesale License is mandatory for any business performing the function of bulk storage and distribution:

• Medical Device Distributors: Businesses supplying devices to hospitals, clinics, dealers, and stockists.
• Importers of Medical Devices: If a company imports medical devices and then stores and distributes them within India.
• Stockists and Dealers: Businesses holding medical device inventory for resale in bulk quantities.
• Online B2B Suppliers: E-commerce and marketplace-based wholesale sellers in medical supplies.
• Manufacturers Selling Through Distribution: If a manufacturer operates a distribution warehouse separately from the production unit, the distribution unit requires an MD 42 License.

What medical devices are covered?

MD 42 applies to Class A and Class B medical devices, such as:

• Syringes, gloves, PPE kits
• Surgical devices and consumables
• Diagnostic equipment
• Dental and orthopaedic devices
• Hospital furniture and general OT equipment

If the devices fall under Class C or Class D, the requirement shifts to a different approval category.

Who issues the MD 42 License?

The license is issued by the State Licensing Authority (SLA) through the CDSCO SUGAM online portal.

Difference Between MD 41 and MD 42

Many new distributors confuse the two. The explanation is straightforward.

If business includes distribution to hospitals, laboratories, nursing homes, government bodies, or dealers, MD 42 is mandatory.

Eligibility and Premises Requirements

The MD 42 approval depends heavily on the physical infrastructure and qualified personnel.

Competent Technical Person (CTS)

A Technical Person (TP) must be employed with one of the following qualifications:

• D.Pharm / B.Pharm / DMLT
• OR Graduate with minimum 1-year experience in medical device sales

Minimum Premises Requirements

The warehouse/storage area must meet high standards for traceability and safety:

• Independent commercial premises with adequate space for storage.
• Temperature & humidity control (where applicable and recorded).
• Clean shelving, pest control, and proper device segregation.
• Computerized or manual record-keeping system for inventory and sales logs.

Who requires a Medical Device Wholesale License?

An MD 42 Wholesale License is mandatory for:

Medical device distributors

Businesses supplying devices to hospitals, clinics, laboratories, dealers and stockists.

Importers of medical devices

If a company imports medical devices and then sells them to the market, an MD 42 License is required for distribution and warehouse storage.

Stockists and dealers

Businesses holding medical device inventory for resale in bulk quantities.

Online B2B medical device suppliers

E-commerce and marketplace-based wholesale sellers in medical supplies and healthcare equipment.

Manufacturers selling through distribution

If a manufacturer also operates a distribution warehouse separately from production, the distribution unit requires an MD 42 License.

Franchise networks and supply-chain companies

Organisations running medical supply franchise models must operate from licensed warehouses.

Required Documents for MD 42 Wholesale License

• Aadhaar and PAN of proprietor / partners / director
• Company registration / GST certificate
• Rent agreement or property papers (proof of premises)
• Warehouse layout and photographs
• Educational documents of the Technical Person
• List of proposed medical devices (classification is key)
• SOPs for storage, handling, complaints, and recall (GDP compliance)

Process for MD 42 Medical Device Wholesale License

• Prepare Commercial Storage Premises: Ensure the warehouse/storage area is suitable for medical devices, with temperature/humidity controls if needed.
• Appoint a Qualified Technical Person: Employ a CTS and prepare their documentation.
• Create Login on CDSCO SUGAM Portal: Register the company on the CDSCO SUGAM portal.
• Prepare and Upload Required Documents: Submit mandatory documents including Company/Premises proof, CTS qualification, and the list of devices.
• Submit Online Application & Fee: Apply through Form MD-41 on SUGAM and pay the government fee (currently ₹3,000 INR).
• Inspection by Licensing Authority: A Drug Inspector visits the storage premises to check storage compliance, record-keeping, and the Technical Person's presence.
• Approval and Grant of License: If successful, the MD 42 Wholesale License is issued digitally.

CDSCO Guidelines for Medical Devices Compliance

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India under the Medical Devices Rules (MDR) 2017 to ensure that all devices supplied in the country are safe, effective and traceable.

Key Compliance Requirements

Correct Device Classification

All devices must be classified based on risk:

• Class A (low risk)
• Class B (low–moderate risk)
• Class C (moderate–high risk)
• Class D (high risk)

Mandatory Licensing

Different business activities require different CDSCO approvals:

• Manufacturing Class A/B – MD-5
• Manufacturing Class C/D – MD-9
• Import – MD-14 / MD-15
• Wholesale – MD-42
• Retail – MD-41

Quality Management System (QMS)

Especially for manufacturers:

• ISO 13485 compliance
• Risk management as per ISO 14971
• Consistent audits and documentation

Labeling & Packaging Rules

Every medical device must include:

• Device name and model
• License number
• Manufacturer / importer details
• Batch / serial number
• Mfg / Exp (if applicable)
• Instructions and storage conditions

Record-Keeping & Traceability

Businesses must maintain:

• Purchase & sales records
• Batch / serial tracking
• Customer / hospital supply records

Post-Market Safety Reporting

Any malfunction, adverse event or repeated complaint must be reported to MvPI.

Retention of License

CDSCO licenses stay valid as long as the retention fee is paid every 5 years.

Silvereye Certifications is trusted by distributors, importers, healthcare chains and startups because our approach removes uncertainty and saves time. Most clients receive approval in one cycle without back-and-forth queries, unlike self-filed applications that often face rejections.

Best Consultant for Medical Devices Compliance

Silvereye Certifications has earned a reputation as one of the Best Consultants for Medical Devices because of:

• Deep understanding of CDSCO regulations
• Error-free documentation and portal filing
• Hands-on support during warehouse inspection
• Transparent communication and predictable timelines

The result is simple: fast approvals, no regulatory obstacles and complete peace of mind.

Conclusion

Businesses entering medical device distribution must secure an MD 42 Wholesale License not only to meet regulatory requirements but also to maintain supply chain reliability and market reputation. Cost and timeline vary based on premises readiness and technical personnel deployment, but with correct documentation and expert assistance, approval becomes straightforward.

For new and expanding distributors, the safest route is to make compliance a foundation rather than a correction. If guidance is required—from documentation to inspection support—professional MD 42 License consultants can ensure zero-error approvals and faster entry into the marketplace. Don't let a compliance gap seize your inventory.