Uttar Pradesh MD-42 License – Application Procedure

In India, strict rules control the sale and stock of medical devices. One key license needed for this is the MD-42 License. This is especially important if you are in Uttar Pradesh. The State Licensing Authority (SLA) issues this license. It allows businesses to sell, stock, show, or offer medical devices. The Medical Devices Rules, 2017 classify these devices.

If you're a wholesaler, retailer, or medical equipment supplier, obtaining a valid MD-42 registration certificate is a legal requirement. In this blog, we will explain how to apply for your MD-42 license. We will cover eligibility, required documents, and costs. Users complete this process through the ONDLS portal in Uttar Pradesh.

What is MD-42 License?

The MD-42 License is a mandatory approval issued under Form MD-42 of the Medical Devices Rules, 2017. You need a license to sell, store, and distribute certain medical devices. This applies to devices that do not classify as notified medical devices. Wholesale dealers, hospitals, diagnostic centers, and companies in the medical equipment supply chain are crucial.

The MD-42 replaces the old drug wholesale license for medical devices. Now, it is only available through the Online National Drug Licensing System (ONDLS) portal.

This license shows that your business meets all technical and regulatory requirements. This includes having the right infrastructure and qualified staff, like registered pharmacists or skilled technical workers. It also means your business follows the rules for handling, storing, and selling medical devices.

Classification of Medical Devices

Medical devices in India are categorized as:

• Class A – Low risk (e.g., thermometers, stethoscopes)

• Class B – Low to moderate risk (e.g., infusion pumps, blood pressure monitors)

• Class C & D – Higher-risk categories, which require MD-43 license instead

MD-42 license covers only Class A and Class B devices. For Class C and D, we follow a different process.

Who Needs to Apply for

MD-42 License? Anyone involved in the sales activity of medical devices must obtain this license. This includes:

• Wholesalers and distributors of medical devices

• Retailers selling medical devices to consumers or clinics

• Online sellers of diagnostic tools and surgical equipment

• Importers wanting to resell devices in India

• Hospital supply vendors or equipment chains

• Diagnostic labs and medical testing centers

E-commerce sellers on sites like Amazon and Flipkart need an MD-42 license. They must meet this requirement if they sell regulated medical devices.

Eligibility Criteria for MD-42 License in Uttar Pradesh

To apply for the MD-42 License in Uttar Pradesh, your business must meet the following eligibility conditions:

Educational Qualification of Technical Staff

You must appoint competent technical staff with either of the following qualifications:

• A degree or diploma in Pharmacy

• A graduate with experience in dealing with medical devices

• A Registered Pharmacist under the Pharmacy Act

• A person who has passed the Intermediate Examination and has at least 1 year of experience with medical devices.

Premises Infrastructure

• The premises for sale or stock must be well-constructed and hygienic

• Must have proper ventilation and storage for temperaturesensitive products

• Adequate space must be available for storing medical devices

Documents Required for MD-42 License

While applying through the ONDLS portal, you need to upload the following documents:

• Identity and address proof of the applicant (Aadhar, PAN)

• Business registration certificate (GST, Trade License, etc.)

• Appointment letter and qualification certificate of competent technical staff

• Affidavit from the technical staff about full-time engagement

• Premises ownership proof or rent agreement

• Layout plan of the storage facility

• Cold storage or air-conditioning details (if required)

• Authorization letter in case of third-party consultant submission

How to Apply for MD-42 License in Uttar Pradesh?

1. Register on the CDSCO SUGAM Portal

The application for MD-42 must be submitted online through the CDSCO SUGAM Portal. Create an account for your firm or business, and select the license type as per your business operations.

2. Fill Form MD-41

• Application for MD-42 license is made using Form MD-41.

• This form includes applicant details, storage facility info, competent technical staff, and list of medical devices.

• Submit the form online via the portal.

3. Upload Required Documents

You must upload all supporting documents in the prescribed format and size. You can find the list referenced below in this blog.

4. Pay Government Fees

The applicable government fee for MD-42 application must be paid online. You must upload the payment receipt along with the application.

5. Inspection by Drug Inspector

The Drug Inspector from the Uttar Pradesh Drug Department may visit your place. They will check your storage area and review your documents.

6. License Grant

Once all documents are verified and inspection is successful, the MD-42 license is issued in digital format.

What is MD-41 License and How is it Different?

Form MD-41 is the official application form used to apply for the MD-42 License. Not an independent license, but a legal document submitted to the State Licensing Authority. This form includes details about the applicant, the premises, and the qualified technical staff.

• MD-41 = Application Form

• MD-42 = License to sell, stock, or distribute medical devices (Class A & B)

In simple terms, you fill MD-41 to get the MD-42 Registration Certificate for selling medical devices.

Conclusion

To get an MD-42 license in Uttar Pradesh, you must have it if you work with Class A and B medical devices. The application is now online through the CDSCO SUGAM portal. This makes the process easier, but it still needs careful handling to prevent delays or rejections.

Let PSR Compliance assist you in obtaining your MD-42 license hassle-free. Our team will ensure complete documentation, application, and coordination with authorities—helping your business stay compliant and operational.

Related Blog:

Read more: Drug License in Haryana

Read more: Introduction to Drug License in Delhi

Read more: How to get a Drug License in Uttar Pradesh (UP)