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The MD 42 License is a certification. The Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLA) issue it. For businesses that sell, stock, distribute, or show medical devices in India. Medical devices vary from low-risk items like thermometers to high-risk products such as pacemakers. They must meet strict safety and quality standards. Each business location must apply for its own MD-42 License. This means that if you have many stores or warehouses in India, each one needs its own license. Also, any online seller of medical devices must upload the MD-42 License to the e-commerce platform. They need this approval before listing any products.
This license ensures that everyone involved has the right tools and staff. This includes importers, retailers, wholesalers, and online sellers. They must also keep records to handle medical devices safely.
After the GSR 754(E) notice in 2022, authorities now require the MD-42 License. This applies to both offline businesses and e-commerce vendors. The aim is to protect consumers and ensure that only approved medical devices sell within India.
Every applicant must appoint a Competent Technical Staff member who will direct and supervise the sale, storage, and distribution of medical devices at the premises. This is a mandatory requirement, and the appointed person must meet at least one of the following qualifications:
Without a qualified Competent Technical Staff member named in your application, your MD-42 submission will be considered incomplete. This person's certificate and experience letter must be submitted along with your other documents at the time of application.
Obtaining an MD-42 License brings several key advantages to businesses involved in the sale or distribution of medical devices:
Before starting your application, keep the following documents ready. Having these in hand upfront makes the registration process much faster and reduces the chances of rejection or delay.
Keeping this checklist ready before you log into the SUGAM Portal will help you complete Form MD-41 in one sitting instead of pausing midway to arrange missing paperwork.
Form MD-41 is the primary application form that businesses must submit to apply for the MD-42 License. It collects critical information about your business, including:
This form is vital because it allows authorities to verify that your business meets the standards set by the CDSCO. A complete and accurate Form MD-41 will ensure faster processing and approval of your application.
Each of these classes requires businesses to ensure safe storage conditions, staff qualifications, and compliance with medical device regulations.
| Particular | Details |
|---|---|
| Application Fee | ₹3,000 per premise (non-refundable) |
| Retention/Renewal Fee | ₹3,000 every 5 years |
| Late Fee Penalty | 2% per month on delayed retention payment |
| License Validity | Lifetime (subject to timely retention fee payment) |
| Processing Time | [not currently stated on page — add real number, e.g. "30–45 working days from application + inspection"] |
| Issuing Authority | State Licensing Authority (SLA), under CDSCO |
| Application Portal | CDSCO SUGAM Portal (Form MD-41) |
| Applicable To | Retailers, wholesalers, distributors, e-commerce sellers, importers, stockists, exhibitors |
| License Revoked If | Retention fee unpaid for 6 months |
| Reapplication | Fresh Form MD-41 required if revoked |
After receiving the MD-42 License, your business must comply with several ongoing obligations:
As online shopping increases, e-commerce sites are changing their rules. Websites like Amazon, Flipkart, and Practo now require all medical device sellers to have a valid MD-42 License.
Sellers must upload their license on the platform before they can list any medical devices. Without this license, you cannot get approval for your products, and you may face suspension of your listings. E-commerce sellers must also ensure that their inventory is compliant with Indian laws and regulations.
At PSR Compliance, we help businesses streamline the MD-42 registration process. Our team has years of experience in assisting clients with:
We make the process simple, fast, and hassle-free, so you can focus on growing your business.
Use the “Search Medical Device” feature on the SUGAM Portal or refer to CDSCO’s notified devices list.
No. All imported devices require MD-42 and import permits (Form MD-14).
SLAs review applications, conduct inspections, and issue MD-42 Licenses.
Yes, as Class A devices (non-sterile).
Submit a “Post-Approval Change” request on SUGAM with updated details.
Fines up to ₹5 lakh, license cancellation, or imprisonment under Section 27 of the Drugs and Cosmetics Act.
Yes, each location requires a distinct MD-42 License.
Yes, if both channels operate under the same business entity.
To get MD-42 registration in Delhi NCR, you need to comply with CDSCO guidelines and submit the required documents. PSR Compliance provides expert assistance to streamline the process.
PSR Assistant