.png)
The healthcare and medical device industry in India has undergone a massive transformation in the last few years — and Haryana is no exception. With the rise of diagnostic centers, medical stores, home-healthcare solutions, and medical device distributors, the need for proper regulatory compliance has become more important than ever.
One of the most essential compliance requirements for anyone involved in the sale, stocking, distribution, or exhibition of medical devices is the MD-42 License. If you are planning to start or expand a medical device business in Haryana, understanding the MD-42 license is not just useful — it’s mandatory.
This article explains everything you need to know about MD-42 License in Haryana, including eligibility, required documents, application process, business benefits, compliance responsibilities, and common challenges businesses face.
What is the MD-42 License?
The MD-42 License is a regulatory certificate issued by the State Licensing Authority (SLA) that permits a business to legally sell, stock, exhibit, or distribute medical devices. It is governed under the Medical Devices Rules, 2017.
In Haryana, the MD-42 license is issued through the State Drug Control Department, and applies to:
- Retail medical stores
- Wholesale distributors
- Stockists and suppliers
- Warehouses handling medical devices
- E-commerce sellers dealing in medical devices
- Businesses that exhibit or display devices for sale
If you are dealing in medical devices at any commercial level, the MD-42 certificate is a must-have.
Who Needs the MD-42 License in Haryana?
You must obtain the MD-42 license if you are involved in:
- Retail sale of medical devices
- Wholesale distribution or bulk supply
- Warehousing, storage, and logistics of medical devices
- Stocking products for resale
- Online sale of medical devices
- Exhibition or display of devices for commercial purposes
Even if you source devices from other states or importers, you still need MD-42 to distribute them within Haryana.
The only exception applies to institutions that purchase devices solely for internal use (e.g., hospitals using equipment for treatment, without resale).
Types of Medical Devices Covered Under MD-42
Before applying, it is important to understand which devices require MD-42. In India, medical devices fall into four categories:
1. Class A – Low Risk
Examples: Bandages, surgical dressings, simple manual equipment, non-sterile devices.
2. Class B – Low to Moderate Risk
Examples: BP monitors, thermometers, sterile bandages, syringes.
3. Class C – Moderate to High Risk
Examples: High-end diagnostic devices, X-ray equipment, dialysis equipment.
4. Class D – High Risk
Examples: Implants, ventilators, advanced life-support systems.
Businesses dealing with products in any of these categories must obtain an MD-42 license in Haryana.
Documents Required for MD-42 License in Haryana
To obtain the MD-42 license, you need to prepare the following documents:
- Business registration document (Proprietorship/Partnership/LLP/Pvt Ltd)
- PAN and GST registration
- Proof of premises (ownership/lease agreement)
- Layout plan of premises or warehouse
- Details of storage facilities (temperature, ventilation, hygiene conditions)
- Appointment letter of the technical staff or competent person
- Qualification certificates of the technical staff
- List of medical devices to be stocked or sold
- Purchase/supplier authorization (where applicable)
- ID and address proof of business owner/authorized person
- Photographs of premises and storage racks
Haryana authorities may also request device-specific documents if the products involve special storage requirements.
Eligibility Criteria for MD-42 License in Haryana
To apply, a business must meet the following conditions:
Proper Storage Facility
The premises must have adequate space, cleanliness, and proper storage racks. Sensitive devices may require cold storage or controlled environments.
Competent Technical Staff
A qualified person must supervise device handling, record-keeping, and compliance.
Valid Business Registration
The entity must be legally registered and maintain all statutory documents.
Compliance with Medical Devices Rules
Businesses must adhere to the Medical Devices Rules, 2017 and any state-specific guidelines applicable in Haryana.
Record-Keeping System
Ability to maintain stock registers, invoices, and batch/lot traceability.
MD-42 Application Process in Haryana: Step-by-Step Guide
Although the process is standardized nationwide, here is how it works specifically for Haryana applicants:
1. Prepare the Premises
Ensure your shop, warehouse, or distribution center meets the required hygiene and storage standards.
2. Collect All Required Documents
Compile business documents, staff details, premises proof, and compliance records.
3. Submit Form MD-41
The application for MD-42 is submitted through Form MD-41, along with the necessary documents and fees.
4. Attend Inspection by State Licensing Authority
An inspector from the Haryana Drug Control Department visits your premises to verify:
- Cleanliness
- Device storage facilities
- Staff qualifications
- Record-keeping systems
- Inventory management
5. Rectify Any Observations (If Provided)
If the inspector identifies gaps, you must resolve them before approval.
6. Receive the MD-42 Certificate
Upon successful verification, the MD-42 license is issued.
7. Display and Maintain the License
The certificate must be displayed prominently at the business premises.
Validity and Renewal of MD-42 License in Haryana
The MD-42 license is often treated as long-term or lifetime valid, but businesses must:
- Maintain ongoing compliance
- Keep records updated
- Pay retention or renewal fees (if required by rule updates)
- Avoid violations during inspections
Failing to do so may result in suspension or cancellation.
Common Mistakes to Avoid During MD-42 Application
Many businesses in Haryana face difficulty due to:
- Incomplete documentation
- Poorly maintained premises
- Not appointing a qualified technical person
- Improper storage conditions
- Lack of clarity on medical device categories
- Delayed response to inspection observations
- Attempting to sell devices without the license
Avoiding these mistakes ensures faster approval and smoother operations.
Benefits of Having an MD-42 License in Haryana
Obtaining the MD-42 license offers several advantages:
1. Legal Authorization
You can operate freely without fear of penalties or seizures.
2. Increased Market Access
Hospitals, clinics, and e-commerce platforms prefer working with licensed sellers.
3. Enhanced Credibility
Licensed distributors are trusted more by customers and suppliers.
4. Smooth Supply Chain
Compliance reduces disruptions during audits or inspections.
5. Opportunities for Expansion
With proper licensing, it becomes easier to expand into new markets or add new device categories.
6. Protection Against Legal Risks
The MD-42 license safeguards your business from regulatory action.
How Medical Device Business is Growing in Haryana
Haryana’s proximity to Delhi NCR and its expanding industrial hubs make it a hotspot for:
- Diagnostic labs
- E-commerce fulfillment centers
- Health-tech startups
- Medical device distributors
- Hospitals and specialized care centers
This rapid growth creates strong demand for legally compliant medical devices — and thus, MD-42 licensing is becoming more essential than ever.
Conclusion
If you're planning to engage in the sale, stock, or distribution of medical devices in Haryana, obtaining the MD-42 license is an absolute necessity. It not only ensures legal compliance but also strengthens your credibility, enhances supply chain efficiency, and protects your business from legal hassles.
As the medical device market in Haryana continues to grow, having the correct license will help you stay competitive, trustworthy, and aligned with national standards.
If you want guidance with documentation, inspection preparation, or end-to-end MD-42 registration support, you can explore expert resources like:
https://www.psrcompliance.com/blog/md-42-license-in-india
Comments