The healthcare sector in India is growing rapidly, and so is the demand for safe and regulated medical devices. If you're a manufacturer, importer, distributor, or seller of medical devices, obtaining an MD-42 license from CDSCO (Central Drugs Standard Control Organization) is a mandatory step.

✅ What is an MD-42 License?
The MD-42 license is issued under the Medical Devices Rules, 2017 by the CDSCO. It is required for entities involved in selling, stocking, exhibiting, offering for sale, or distributing medical devices that are classified under various risk categories (Class A, B, C, or D).

It is issued in Form MD-42 after submitting an application via Form MD-41.

🏥 Who Needs an MD-42 License?
Any business or individual in India engaged in the retail or wholesale of medical devices must obtain this license. This includes:
Medical device wholesalers
Medical equipment distributors
Stockists
Online medical device sellers
Importers with domestic sale operations

📋 Documents Required for MD-42 License Application
You need the following documents to apply for the MD-42 license:

Application in Form MD-41
Covering letter detailing the purpose and product category
Valid wholesale drug license (if applicable)
Details of the applicant – name, contact, business type
Proof of ownership/rent agreement of premises
Site plan & key plan of the storage facility
List of medical devices to be sold
Details of competent technical staff (qualification & experience)
Declaration of compliance with the Medical Devices Rules
Fee payment receipt (via Bharatkosh portal)

📝 Step-by-Step Process to Apply for MD-42 License in India
Here is a simple breakdown of how to apply:

Register on the CDSCO SUGAM portal
Create an account and validate with your business credentials.
Fill out Form MD-41 online
Enter applicant, firm, and premises details.
Upload documents
Ensure all files are in proper format (PDF) and size limit.
Pay Government Fees
Use Bharatkosh to pay the applicable fee for Form MD-42 license.
Submit the Application
Once submitted, it will be reviewed by the concerned CDSCO officer.
Site Inspection (if required)
Depending on the device class, CDSCO may conduct an inspection.
License Issuance (Form MD-42)
If approved, your license will be issued digitally.

📌 Important Compliance Points
License is valid for five years, subject to retention fee.

Display the license prominently at your business premises.

Maintain records of sales, purchases, and distribution.

Report any adverse events related to the devices.

Renew or retain your license before the expiry period.

🌐 Need Help with MD-42 License?
At PSR Compliance, we help businesses navigate complex compliance requirements with ease. From documentation to end-to-end filing and follow-up, our experts ensure your MD-42 license is obtained without delays.

To get started, visit https://www.psrcompliance.com/blog/md-42-license-in-india