MD 42 License Registration in Delhi NCR and Haryana

MD 42 License Registration in Delhi NCR and Haryana

The MD 42 License is the official Registration Certificate. You must get this from the State Licensing Authority (SLA). This document lets you legally sell, stock, exhibit or distribute medical devices and in-vitro diagnostic devices (IVDs) in Delhi-NCR and Haryana. The Central Drugs Standard Control Organization (CDSCO) brought in the Medical Devices Rules 2017. These rules control this certificate. This new rule moves medical device regulation away from older drug rules, which is important. Every business, whether wholesaler, retailer, or stockist, must get this MD 42 certificate. You must secure it to operate lawfully.

Importance of MD 42 License

The Government of India introduced the Medical Devices Rules (MDR) 2017. These rules make medical device safety and quality a top focus. MD 42 is part of this focus. It means authorities treat medical devices as separate from drugs. This separation creates a clearer, specialized regulatory structure for your products.

Applicable Devices. Who Needs This

The MD 42 registration applies to the sale and distribution of all notified medical devices and IVDs. This covers all risk classes:

• Class A and B Devices. These devices are low to moderate risk. Examples include surgical dressings, syringes and thermometers
• Class C and D Devices. These devices are moderate to high risk. Even though the manufacturer needs a tougher license for these, the distributor or stockist must still have the MD 42 license to legally handle them.

Finding Your Regulator. Delhi vs. Haryana

Delhi and Haryana are both part of the NCR region. But, they have different licensing authorities. You must apply to the correct one based on your physical location.

• For Delhi. The Drug Control Department Government of NCT of Delhi is your licensing authority. This department handles applications for premises within the National Capital Territory.
• For Haryana. The Food and Drug Administration (FDA), Haryana, is your licensing authority. This body controls the licensing process for Gurugram, Faridabad, and all other locations in Haryana.

Read More MD 42 License Registration in Uttar Pradesh

Step-by-step Process to Get MD 42 Certificate

The application process is mostly online now. You must submit your application through the CDSCO SUGAM Portal

Step 1. SUGAM Portal Registration

You must first register your company on the CDSCO SUGAM portal. You create a user ID. You upload your basic company documents, like the Certificate of Incorporation and PAN card. This step gives you access to the online licensing application system. You will select the specific license you need, Form MD 41.

Step 2. Assembling Your Documents

The Licensing Authority rigorously checks all submitted documents. You must have all paperwork ready and correct. Errors cause rejections, you know.

Key Documents You Must Provide

• Company Proof. This includes the Certificate of Incorporation (if applicable) or the Partnership Deed. Also, the valid GST Registration Certificate and the PAN card for the business entity are needed.
• Premises Details. You need proof of ownership for your storage and sale space. This proof can be a Sale Deed or a notarized Rent/Lease Agreement for at least five years. You must submit a detailed, certified layout plan of the premises.
• Competent Technical Staff. You must appoint a qualified person to supervise all sales activities. This person must be an employee. They must meet specific criteria. A degree in Pharmacy, or a graduate degree with one year of experience in medical device sales, or a registered pharmacist are all acceptable! You must provide their qualification certificates and a formal acceptance letter for the role.
• Undertakings. You give a formal undertaking. This document confirms your premises comply with the Good Distribution Practices (GDP) for medical devices.

Step 3. Verification and Inspection

After you submit the Form MD 41 and pay the government fees (Rs. 3000) the relevant State Licensing Authority begins verification

A Drug Inspector from the Delhi Drug Control Department or the Haryana FDA may conduct an on-site physical inspection.

The Inspector will check for these things:

• Storage Conditions. TThe space must be adequate for device storage. If your devices need cold storage (like certain diagnostic kits) they verify the refrigerator logs. The premises must be clean
• Record Keeping. You must show proper sales and purchase invoices, tracking device batch numbers. You must maintain these records for at least two years from the last entry date
• Competent Staff. They confirm that the appointed technical person is working full-time at the location.

Step 4. Issuance of the MD 42

If the State Licensing Authority feels satisfied with the documents, the fees and the inspection report they issue the MD 42 Registration Certificate. This certificate is a legal grant for your business. It is valid indefinitely, but you must pay a retention fee every five years to keep it active. You must display this certificate clearly on your business premises for all to see.

Read More MD 42 License Registration Certificate Medical Device Wholesale

Conclusion

The regulatory landscape changes often. New rules come out fast. The government updates guidelines for device classifications. This means businesses in Delhi-NCR and Haryana must adopt a broad mindset. You should not treat compliance as a one-time activity! You must build regulatory checks right into your daily operations. Do you need help navigating these changes smoothly? Contact our experts at Agile Regulatory and secure your MD 42 license without delay