The medical device market in India is rapidly growing in 2026, creating significant opportunities for distributors and stockists. To operate legally, businesses dealing with high-risk medical devices must obtain the MD-42 license CDSCO.
Unlike manufacturing licenses, the MD-42 license focuses on distribution, stocking, and sales of Class C and D medical devices. Holding this license ensures regulatory compliance, safety, and credibility in the healthcare industry.
What is MD-42 License?
The MD-42 license CDSCO is a mandatory regulatory authorization for businesses involved in selling or stocking Class C and D medical devices in India.
With this license, distributors can legally:
Stock medical devices for hospitals and clinics
Distribute products to pharmacies and other healthcare providers
Ensure compliance with safety and traceability standards
Businesses without an MD-42 license risk penalties, including fines, confiscation of products, and legal action.
Importance of MD-42 License for Distributors
Obtaining the license offers multiple benefits:
Legal operations – Avoid legal complications while distributing medical devices
Market trust – Hospitals and clinics prefer licensed distributors
Traceability and safety – Ensures proper handling and storage of high-risk devices
To understand which devices fall under this license, distributors refer to the CDSCO medical device Classification list. At the same time, an MD-42 license Consultant can guide businesses on preparation, documentation, and inspections.
Medical Device Classification
Devices are classified into four categories according to the CDSCO medical device Classification list:
Class A – Low risk, e.g., bandages
Class B – Low-moderate risk, e.g., syringes
Class C – Moderate-high risk, e.g., infusion pumps, orthopedic implants
Class D – High risk, e.g., heart valves, stents, ventilators
Distributors must ensure that only Class C and D devices are included in their MD 42 license product list, which is required for application.
MD 42 License Product List
Preparing an accurate MD 42 license product list is crucial. It defines all the devices a distributor intends to stock or sell.
Key points for the product list:
Align with the CDSCO medical device Classification list
Include device name, model, batch, and risk class
Reference any items listed under the MD-15 license item list
Maintaining an updated product list ensures smoother inspections and regulatory compliance.
MD 42 License Cost
The MD 42 license cost varies based on factors such as:
Number of devices included in the MD 42 license product list
Application and inspection fees charged by CDSCO
Consultancy fees, if an MD-42 license Consultant is hired
A proper estimate of MD 42 license cost helps distributors plan their budgets effectively.
Eligibility Criteria for Distributors
Distributors applying for an MD-42 license must fulfill these conditions:
Premises – Clean and secure storage space meeting regulatory standards
Qualified Person – Competent personnel overseeing storage and compliance
Storage Conditions – Temperature-controlled systems for sensitive devices
Documentation – Maintain proper records of purchase, sale, batch, and expiry
Even if operations are based in Delhi NCR or Noida, compliance with these standards is required.
Application Process
The steps to obtain the MD-42 license include:
Document Preparation – Collect ID, premises proof, competent person certificate, and the MD 42 license product list
Application Submission – Submit through CDSCO or the State Drug Authority
Inspection – CDSCO officials verify premises and documentation
License Grant – After verification, the license is issued
Consulting an MD-42 license Consultant ensures documents are accurate and inspections are passed smoothly.
Common Mistakes to Avoid
Submitting an incomplete MD 42 license product list
Using premises that do not meet storage or hygiene standards
Lack of a competent person to oversee operations
Poor record-keeping of batches and sales
Correct preparation and guidance from a MD-42 license Consultant help avoid these common pitfalls.
Benefits of MD-42 License for Stock and Distribution
Legal Operations – Distribute devices safely without regulatory issues
Market Credibility – Trusted by hospitals, clinics, and pharmacies
Traceability – Maintain batch-wise records for safety and audits
Nationwide Distribution – Sell and stock devices across India
Professional Support – An MD-42 license Consultant can guide through every step
Regional Considerations – Delhi, Noida, and India
Businesses in Delhi NCR and Noida have high demand due to dense healthcare networks. Key factors for license approval in these regions:
Ensure premises comply with local zoning and cleanliness standards
Temperature-controlled storage for sensitive devices
Employ qualified personnel for compliance oversight
Maintain an updated MD 42 license product list and reference MD-15 license item list
Professional consultants help businesses align with both regional regulations and CDSCO requirements.
Role of MD-42 License Consultant
An MD-42 license Consultant supports distributors by:
Preparing the MD 42 license product list
Calculating the MD 42 license cost
Guiding through application and inspection processes
Ensuring storage compliance and record maintenance
Coordinating with CDSCO for quick approval
Consultants ensure the process is error-free and approval timelines are reduced.
CDSCO/FAQ Medical Devices
Distributors can refer to CDSCO/FAQ medical devices to understand:
Device categories requiring MD-42 licensing
Inspection procedures and documentation requirements
Amendments or renewal processes for MD-42 license
Staying updated with CDSCO FAQs helps maintain compliance and avoid penalties.
Conclusion
The MD-42 license CDSCO is essential for legally stocking, distributing, and selling Class C and D medical devices in India.
Key takeaways for distributors:
Maintain an accurate MD 42 license product list
Follow the CDSCO medical device Classification list
Calculate the MD 42 license cost
Check the MD-15 license item list for device-specific requirements
Consult CDSCO/FAQ medical devices for guidance
Hire an MD-42 license Consultant for professional support
Obtaining the MD-42 license ensures legal compliance, credibility, and nationwide business growth in 2026 and beyond.
Contact Us
Company Name: PSR Compliance
Phone: +91 7065883416
Email: support@psrcompliance.com
Office Address: D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301
Website :https://www.psrcompliance.com/
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