In India, the medical device industry is rapidly expanding, driven by innovation, technology, and growing healthcare needs. However, to ensure safety and quality, medical devices must meet specific regulatory standards. One of the most important regulatory requirements for medical device distributors is the MD 42 license.
If you are planning to start distributing or selling medical devices in India, understanding how to get an MD 42 license, the MD 42 license cost, and the complete application process is essential. This guide breaks it down in simple terms, so you can make informed decisions and stay compliant.
What Is an MD 42 License?
An MD 42 license (also known as MD-42) is an authorization issued by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. It permits a business to distribute, sell, stock, or exhibit medical devices in India.
Essentially, if your company is engaged in the trade, marketing, or distribution of medical devices — whether imported or manufactured domestically — you must obtain this license before beginning operations.
The MD 42 certificate serves as a mark of compliance with India’s Medical Device Rules, ensuring that only registered, high-quality devices reach hospitals, clinics, and patients.
Why the MD 42 License Is Important
In recent years, India has aligned its medical device regulations closer to global standards. Obtaining an MD 42 license ensures that your business:
Operates legally under the Medical Device Rules, 2017.
Builds credibility with hospitals, healthcare institutions, and regulatory bodies.
Ensures patient safety by dealing only in approved and verified devices.
Avoids penalties or legal action for unauthorized sales or distribution.
Without this license, distributing medical devices in India can lead to regulatory issues, fines, or even closure of business operations.
Who Needs an MD 42 License?
You must apply for an MD 42 certificate if your business:
Sells or distributes medical devices (class A, B, C, or D) in India.
Stocks or exhibits medical devices for sale.
Acts as an importer, wholesaler, or distributor of medical devices.
Even if your business is based in one state but distributes across India, the MD 42 license applies to you.
For example, if you operate in the capital city, you will need to obtain the MD 42 license in Delhi through the State Licensing Authority. Each state has a designated department to issue the license for that region.
Step-by-Step Process: How to Get MD 42 License
The process for obtaining an MD 42 license involves online application, document verification, and inspection. Here’s how it works step-by-step:
Identify the Appropriate Class of Devices
Medical devices are categorized into four classes — A, B, C, and D — based on risk. Class A and B are low to moderate-risk devices (e.g., surgical gloves, thermometers), while Class C and D are higher-risk devices (e.g., heart valves, stents).Register on the CDSCO Portal
The application for the MD 42 license is filed online via the CDSCO portal. You’ll need to create an account and provide your organization’s details, authorized personnel, and premises information.Prepare the Required Documents
Common documents required for MD 42 registration include:Proof of business constitution (partnership deed, incorporation certificate, etc.)
Details of the firm’s premises (ownership or rental agreement)
Site plan and layout of storage area
Qualification and experience proof of the competent technical person
Device list with class details
ISO certification (if applicable)
Self-declaration of compliance
Submit the Application Online
Once documents are ready, the applicant files Form MD-42 online along with supporting details.Inspection by Licensing Authority
After submission, the authority may conduct an inspection of the premises to ensure that storage conditions, hygiene, and safety standards meet regulatory norms.License Approval
If all conditions are met, the authority issues the MD 42 license — authorizing your business to sell or distribute medical devices legally.
The process can take a few weeks depending on documentation accuracy and inspection timelines.
MD 42 License Cost
The MD 42 license cost can vary depending on factors such as:
Number of devices or categories applied for.
State licensing authority’s applicable charges.
Professional or consultant fees (if applicable).
On average, the government fee is nominal, but total expenses may range higher once you include documentation, certification, and consultancy costs.
Having a clear understanding of costs upfront can help you plan your compliance budget better.
Key Requirements for Holding an MD 42 License
To maintain a valid MD 42 license, your business must adhere to certain ongoing requirements:
Maintain records of purchase, sale, and stock for all devices.
Ensure the storage facility meets required environmental and safety conditions.
Report any adverse incidents related to the devices.
Display the license prominently at the business premises.
Renew or update the license if there is any change in business structure or address.
Meeting these compliance standards not only avoids penalties but also ensures consistent credibility and trust with healthcare buyers.
Common Mistakes to Avoid
Incomplete documentation — Missing or inaccurate details can delay the process.
Ignoring renewal deadlines — Even though the license has long validity, failure to renew or update can cause suspension.
Non-compliant premises — Improper storage or handling conditions can lead to rejection during inspection.
Unregistered products — Selling medical devices not listed under the license can result in penalties.
Avoiding these mistakes helps maintain your business reputation and keeps your license in good standing.
MD 42 License in Delhi
If your operations are based in Delhi, you must apply through the Delhi State Licensing Authority. The MD 42 license Delhi process follows similar guidelines but may include state-specific documentation or inspection steps.
Since Delhi serves as a major hub for medical distributors and healthcare suppliers, obtaining this license not only ensures compliance but also strengthens your standing in one of India’s most active healthcare markets.
How PSR Compliance Can Help
Applying for a license to distribute medical devices in India can seem overwhelming — especially if you are new to regulatory processes. This is where PSR Compliance can make a difference.
Here’s how PSR Compliance supports businesses in obtaining the MD 42 license efficiently:
Expert Consultation: Their professionals guide you through eligibility, documentation, and the complete process of how to get an MD 42 license.
Hassle-Free Filing: PSR handles form submission, document review, and application tracking — saving time and effort.
Transparent Cost Guidance: They help estimate your MD 42 license cost accurately with no hidden charges.
Post-Approval Support: PSR ensures you stay compliant with renewal, updates, and audit readiness.
With the right guidance, your business can easily navigate the regulatory landscape and focus on growth rather than paperwork.
To learn more or start your application, visit:
👉 https://www.psrcompliance.com/md-42-license
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