A manufacturing licence lets you make a device. An import licence lets you bring one into India. Neither of them lets you sell it onward. That is what the MD-42 wholesale registration is for, and it is the licence most often discovered late — usually when a hospital or government buyer asks for it during tendering.
What MD-42 is
Under the Medical Devices Rules, 2017, anyone who sells, stocks, exhibits or offers for sale, or distributes a medical device must hold a wholesale registration. The application is made in Form MD-41 and the registration certificate is granted in Form MD-42 by the State Licensing Authority.
It is a registration rather than a licence in the older sense, and it is granted per premises. Three warehouses in three states means three registrations, not one with three addresses.
Who needs it
- Distributors and dealers buying from a manufacturer or importer and selling onward.
- Importers who also distribute. An MD-15 import licence covers import. The moment the imported stock is sold to a hospital, dealer or institution, wholesale registration is engaged.
- Manufacturers selling directly to end users from a separate sales premises rather than the licensed factory.
- Online sellers and marketplaces holding stock of medical devices.
- Government tender participants. Most tenders now ask for it by name, which is why it surfaces at the worst possible moment.
What the application needs
The substance of an MD-41 application is straightforward, but two elements decide whether it moves quickly:
- Competent technical staff. The rules require a registered pharmacist, or a graduate with one year of experience in dealing with medical devices, or a person with four years of such experience. Their qualification documents, appointment letter and consent form the spine of the application.
- Adequate premises. A defined minimum area, with storage conditions appropriate to the devices held, including refrigeration where the products require it. A floor plan and proof of ownership or a registered lease are expected.
Beyond those: the constitution documents of the firm, the device list with classifications, an undertaking on compliance, and the prescribed fee. Where the applicant is also the importer, the MD-15 import licence is filed alongside.
Timeline and validity
Processing sits with the State Licensing Authority, and speed varies considerably between states. Plan on several weeks rather than days, and longer if an inspection of the premises is called for. The registration remains valid subject to the retention fee being paid and the conditions being maintained — the modern rules moved away from fixed-term renewal towards continuing validity with periodic fees, so the operational risk is a missed fee rather than a forgotten renewal date.
Where applications go wrong
- The technical person does not meet the qualification on paper. Experience has to be evidenced, not asserted. Appointment letters and experience certificates from previous employers are what the authority reads.
- The premises are shared or undersized. A desk in a corner of an office is not a wholesale premises. Where cold chain products are held, the storage evidence has to match the claim.
- The device list is vague. List devices by name, class and intended use, consistent with the manufacturer’s or importer’s own licence. A mismatch between your list and the upstream licence is a query.
- One registration assumed to cover several premises. It does not. Each stocking location needs its own.
- Applying after the tender opens. The commonest and most expensive mistake. Registration is a prerequisite, not a formality to be completed after award.
Frequently asked questions
Do we need MD-42 if we already hold an import licence?
Yes, if you sell or distribute the imported devices in India. The MD-15 import licence authorises import. Wholesale registration authorises sale, stock and distribution. They cover different activities.
Does a manufacturer need wholesale registration?
Not for selling from the licensed manufacturing premises. If you operate a separate depot, warehouse or sales office that stocks and sells devices, that premises needs its own registration.
Can one registration cover multiple states?
No. It is granted per premises by the State Licensing Authority of that state. Each location needs a separate application.
Who can be the competent technical person?
A registered pharmacist, or a graduate with at least one year of experience in dealing with medical devices, or a person with at least four years of such experience. The qualification and experience must be documented.
What is the difference between Form MD-41 and Form MD-42?
MD-41 is the application you file. MD-42 is the registration certificate the authority grants.
Medfins International prepares and files MD-41 applications, advises on premises and technical staffing before you commit to a lease or a hire, and manages authority queries through to grant. See our MD-42 wholesale registration support, alongside the CDSCO import licence route, or the full list on our services page.
