MD-42 Licence for Medical Device Sale and Distribution
An MD-42 licence is the registration certificate a trader or distributor needs to stock, sell and distribute medical devices. You apply in Form MD-41 on the Medical Devices portal, and the State Licensing Authority issues the certificate. We prepare the papers, file the application and answer the authority.
What it is
MD-42 is the registration certificate for people who deal only in medical devices at the stocking, selling and distribution stage. You apply in Form MD-41 under the Medical Devices Rules, 2017, and the State Licensing Authority issues the certificate in Form MD-42.
It works as an alternative to a wholesale drug licence under the Drugs and Cosmetics Rules, 1945, for businesses that trade in medical devices exclusively. The certificate is valid in perpetuity, but the holder pays a retention fee every five years. Fees are listed in the Second Schedule of the Rules.
Take a Delhi-NCR distributor who supplies glucometers and BP monitors to local clinics. A hospital buyer asks for the firm’s certificate before placing a purchase order. Without MD-42 the order simply goes elsewhere. Retailers and clinics that sell devices over the counter should ask us which route fits them, because this certificate is built for stocking and distribution.
Who it applies to
Medical device distributors
A distributor who buys from manufacturers or importers and supplies hospitals, clinics and dealers needs the certificate before stocking devices.
Traders and wholesalers of devices only
If your business sells nothing but devices such as BP monitors, glucometers, syringes or surgical items, MD-42 can replace a wholesale licence.
Warehouse and e-commerce sellers
A seller shipping devices from a warehouse stocks and distributes them too. Check with us before you list devices on any marketplace.
Why it matters
Legal footing to trade
Manufacturers, importers and hospital buyers ask for your certificate before supplying or buying. It shows you are authorised for the premises.
One licence, no drug wholesale papers
Where you deal only in devices, you can use this route in place of a wholesale drug licence.
Perpetual, with light upkeep
The certificate does not expire. You pay a retention fee every five years and keep your records in order.
Documents required
About the business
- Constitution documents: firm deed, LLP agreement or company incorporation papers
- PAN of the entity and ID proof of the proprietor, partners or directors
- GST registration, where applicable
About the premises
- Proof of ownership or a rent agreement with the owner NOC
- Layout plan or description of the stock area
- Photographs of the premises and storage facility
About the products and people
- List of devices you plan to stock and supply
- Supplier details such as manufacturer or importer licence copies
- Details of the person in charge of the business, as the portal requires
How it works
Check your scope
We confirm whether you deal only in devices. If medicines are also on your shelves, you need a drug licence as well, and we plan both together.
Prepare the premises and papers
We review your premises documents, constitution papers and device list, and tell you what needs fixing before you apply.
File Form MD-41 online
We submit the application with documents and the prescribed fee on the Medical Devices portal for your State Licensing Authority.
Answer queries and collect MD-42
If the authority raises questions, we reply with the right documents. Once satisfied, it issues Form MD-42.
Timelines
Issue time
The State Licensing Authority may issue Form MD-42 within ten days of the application, provided the data is found satisfactory.
Validity
The certificate is issued in perpetuity. You are not renewing it every year or every three years.
Retention fee
Pay the registration certificate retention fee every five years to keep the certificate in force. We diarise it for you.
What happens if you trade without it
Action under drug law
Medical devices are regulated under the Drugs and Cosmetics Act, 1940. Stocking or selling without the required authorisation can attract the penal provisions of that Act.
Suppliers can refuse you
Manufacturers and importers who follow the rules will not supply a dealer who cannot show a valid certificate.
Inspection trouble
Inspectors can ask for your certificate at the premises. Getting it first keeps your stock and your business clear of questions.
Frequently asked questions
What is an MD-42 licence?
MD-42 is the registration certificate issued by the State Licensing Authority to a trader or distributor who stocks, sells and distributes medical devices. You apply in Form MD-41 on the Medical Devices portal. It is valid in perpetuity, with a retention fee every five years. We prepare the application and file it for you.
Who needs an MD-42 licence?
Anyone who deals exclusively in stocking, sale and distribution of medical devices needs it, as an alternative to a wholesale licence under the Drugs and Cosmetics Rules. This covers distributors, wholesalers and dealers who sell only devices. If you also sell medicines, a drug licence is separate, and we can advise on both.
What is the difference between MD-41 and MD-42?
MD-41 is the application form and MD-42 is the certificate you receive. You file MD-41 with documents and the prescribed fee on the Medical Devices portal. After the State Licensing Authority is satisfied with your data, it issues the registration certificate in Form MD-42. We handle both steps.
How long does it take to get MD-42?
The State Licensing Authority may issue MD-42 within ten days of the application, provided the data is found satisfactory. Delay usually comes from missing premises documents or unclear device lists. Getting these right before filing is the quickest route. We check your file first so queries are minimal.
Does the MD-42 licence expire?
No. It is issued in perpetuity. You must, however, pay a registration certificate retention fee every five years. We keep a reminder for every client so the retention fee is paid on time and your certificate stays in force.
Is MD-42 different from a drug licence?
Yes. A drug licence under the Drugs and Cosmetics Rules covers medicines, while MD-42 is for devices only. If you trade exclusively in devices, MD-42 can stand in for a wholesale licence. If you sell both medicines and devices, plan for both, and we can coordinate them together.
Who issues the MD-42 certificate?
The State Licensing Authority of the state where your premises are issues it. You choose your state on the Medical Devices portal when you apply. We file on the portal and follow up with the authority on your behalf.
What fee applies to MD-41?
The fee is prescribed in the Second Schedule of the Medical Devices Rules, 2017, and is paid when you apply. The retention fee falls due every five years after that. Since schedules can be amended, we confirm the current figure before filing and quote it with our fee, so nothing surprises you.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fees for MD-41 and the five-yearly retention fee are set in the Second Schedule of the Medical Devices Rules, 2017. We confirm the current amount for your case when we quote.
Ready to begin?
Share your premises and product list, and we will get your MD-41 application ready for the State Licensing Authority.