MD-42 License in India: How to Apply for Medical Device Wholesale and Retail Registration

The MD-42 License in India: Registration to Sell and Distribute Medical Devices

The MD-42 license is the registration certificate that allows a business to sell, stock, exhibit, offer for sale or distribute medical devices, including in-vitro diagnostic (IVD) devices. It was introduced by the Medical Devices (Fifth Amendment) Rules, 2022, notified as G.S.R. 754(E) on 30 September 2022. The application is made on Form MD-41 to the State Licensing Authority, and the certificate is issued on Form MD-42. In India, the State Licensing Authority is the State Drug Licensing Authority.

Before this change, many surgical and device dealers worked without any registration because devices were only partly regulated. Now that every class of medical device is regulated, the businesses that sell them must be registered too. Distributors, stockists, surgical dealers, hospital suppliers and retailers that deal in medical devices, and do not already hold a license that covers them, need an MD-42 registration certificate.

Regovex Consulting is a drug license consultant and CDSCO registration consultant with a dedicated medical device practice. We confirm whether MD-42 is the right registration for your business, prepare the Form MD-41 application with the competent person, premises and storage documents, file it online, answer queries within 24–48 hours, and set up the records and Good Distribution Practice routines you need after registration.

MD-42 at a glance

Who Needs an MD-42 Registration in India?

If your business sells or distributes medical devices in India, you probably need MD-42. That includes:

• Medical device distributors and stockists supplying hospitals, clinics, laboratories and retailers
• Surgical and orthopaedic dealers selling instruments, disposables, braces, supports and mobility aids
• Hospital and institutional suppliers of consumables, equipment and IVD kits
• Diagnostic distributors selling IVD reagents, rapid tests and analysers to laboratories
• Retail shops selling devices such as BP monitors, glucometers, thermometers, nebulisers and supports
• Online sellers and B2B platforms that hold device stock and sell it
• Equipment dealers selling and installing medical equipment

Manufacturers selling their own licensed devices, and importers selling their own imported devices from licensed premises, are already covered by their manufacturing or import licenses. A separate warehouse or a sale to the public by another business may still need a registration, which we check case by case.

Medical Device Wholesale License for Different Business Types in India

The MD-42 registration works as a medical device wholesale license and a retail registration at the same time: the same certificate covers selling to hospitals, to other dealers and to the public. What changes from one business to another is the paperwork buyers ask for and the storage and records inspectors expect.

Hospital and institutional suppliers

Hospitals, nursing homes and government tenders usually ask suppliers for a copy of their MD-42 certificate or drug license, the manufacturer's or importer's license for each device, and proof of batch traceability. A supplier that cannot produce these is often disqualified at the technical bid stage, so the medical device wholesale license is as much a sales document as a legal one.

Diagnostic and IVD distributors

Distributors of rapid tests, reagents and analysers deal in products with short shelf lives and strict storage conditions. Their registration file should show refrigerated storage for 2–8 °C products, temperature logs, and a first-expiry-first-out stock system. Inspectors often check expiry dates on the shelf.

Surgical and orthopaedic dealers

Surgical dealers sell instruments, disposables, dressings, braces and supports, often from compact shops. The main points are clean storage off the floor, separation of sterile and non-sterile items, and purchase invoices showing licensed sources for every product line.

Dealers who ask for a surgical instruments wholesale license are usually device-only businesses, so MD-42 is the registration that applies. If you also stock medicines such as antiseptics or injections, a surgical instruments wholesale license on its own is not enough, and the drug side needs a Form 20B and 21B wholesale drug license.

Equipment dealers with installation and service

Dealers who sell and install monitors, ventilators, infusion pumps or laboratory equipment need MD-42 for the premises where equipment is stocked or displayed. Service and installation records, including serial numbers and the customer's details, also help with recalls and field safety notices.

Online sellers and B2B platforms

Online sellers that hold device stock need MD-42 for every warehouse from which they dispatch. Batch-wise records of each order make returns, complaints and recalls manageable, and many platforms ask sellers for the registration before listing devices.

Pharmacies expanding into devices

A pharmacy or drug wholesaler with a valid drug license has generally been able to sell devices alongside medicines. When a pharmacy opens a separate device-only showroom or godown, that new premises may need its own MD-42. We check this before the new premises opens.

Medical Device Distributor License in India: One MD 42 License, Many Names

Business owners search for this registration under many names. A medical device distributor license, a medical device dealer license, a medical device stockist license and a license for selling medical devices all point to the same legal document: the MD 42 license, formally the registration certificate in Form MD-42 granted on an application in Form MD-41. Knowing this saves you from paying for the wrong service or filing under the wrong category on ONDLS or your state drug licensing portal.

The medical device distributor license in India is therefore not a separate central licence. It is a state-level registration: the MD-41 application goes to the State Licensing Authority of the state where your premises are, which in India is the State Drug Licensing Authority. Once granted, the MD 42 certificate names the firm, the premises address and the competent person, and it must be displayed at that premises. A trader who searches for medical device trader registration India, or a shop owner who asks for a medical equipment shop license, is asking for this same MD 42 license, and Regovex files it under the correct form and category for your state.

MD-42 vs Drug Wholesale License vs Other Device Licenses

The MD-42 registration is one of several licenses in the medical device supply chain. Choosing the right one depends on what you do with the device.

MD 42 vs 20B 21B wholesale license: if you already hold a drug license

The 2022 amendment requires registration from persons who sell devices and do not already hold a license for that activity. Pharmacies and drug wholesalers with a valid retail or wholesale drug license have generally continued to sell devices under that license. However, practice differs between states and some licensing authorities ask device-heavy businesses to register separately. If most of your sales are devices, or you are opening a separate device-only outlet or warehouse, we confirm the current position with the State Drug Licensing Authority before you rely on your drug license.

In short, the MD 42 vs 20B 21B wholesale license question comes down to what you sell. A Form 20B and 21B wholesale drug license is built for medicines and needs a qualified competent person and drug storage; an MD-42 registration is built for devices and is simpler to obtain. A drug wholesaler that adds a device-only warehouse, or a device dealer that starts stocking medicines, may need both. We map your product list against both licences before you file.

Device-only businesses

A surgical dealer, diagnostic distributor or equipment supplier with no drug license needs an MD-42 registration for each premises from which it sells or stocks devices. This includes godowns where stock is held before dispatch.

Importers and manufacturers

An importer holding an MD-15 import license and a manufacturer holding an MD-5 or MD-9 license can sell their own devices under those licenses. Their distributors and dealers, however, need their own MD-42 registration or drug license.

Which Medical Devices Does an MD-42 Registration Cover?

An MD-42 registration covers the sale, stock, exhibition and distribution of medical devices of all classes, including IVDs. In practice, MD-42 holders in India commonly deal in:

• Consumables and disposables: syringes, needles, catheters, gloves, dressings, cannulas
• Diagnostic devices and IVDs: rapid test kits, reagents, glucometers and strips, analysers
• Home-use devices: BP monitors, thermometers, nebulisers, pulse oximeters
• Surgical instruments and orthopaedic products: instruments, implants supplied through distributors, braces and supports
• Equipment: patient monitors, ventilators, infusion pumps, imaging and laboratory equipment

The registration itself does not change with the device class, but your storage, handling and records do. Cold-chain IVD reagents, sterile disposables and implants each need the right storage conditions and traceability, and inspectors check them against the devices you actually stock.

Storage requirements by device type

Your MD-41 storage undertaking should describe the storage you actually have for the devices you actually stock. A mismatch between the undertaking and the shop is a common inspection finding.

Eligibility for an MD-42 License in India

To get an MD-42 registration certificate in India, a business needs three things in place before applying.

1. Competent technical staff with one of the qualifications accepted under the rules (see the table below).
2. Suitable premises with adequate space and proper storage conditions, including temperature and lighting suited to the devices stocked.
3. A commitment to Good Distribution Practice, given as a self-certificate with the application, covering how devices are bought, stored, sold and recorded.

Competent technical staff for MD-42

The application must name a competent person who meets any one of these routes:

The competent person should work for your business and be available at the premises. Many small dealers name the proprietor if they meet one of these routes. If the competent person leaves, appoint a replacement and update the licensing authority.

Premises and storage

• Premises that are legally usable for commercial business, with ownership or a rent agreement in the applicant's name
• Enough space to store devices off the floor, by type and batch, with separate areas for expired, damaged or returned stock
• Temperature control where devices need it, such as IVD reagents and some kits stored at 2–8 °C
• Protection from direct sunlight, moisture, dust and pests
• A clear statement of any other business carried on at the same premises
• The registration certificate displayed where the public can see it

MD 42 License Documents Required: Checklist for the MD 41 Form

The MD-41 application is simpler than a manufacturing file, but every document must match. A complete application in India usually includes:

• Applicant details: name, constitution (proprietorship, partnership, LLP or company) and contact details of the firm
• Identity proof: Aadhaar or PAN of the proprietor, partners or directors
• Premises proof: ownership deed, or rent agreement with the owner's proof of ownership
• Site or layout plan showing the storage area
• Description of other activities carried on at the premises, if any
• Competent person documents: qualification certificate, pharmacist registration or experience letter, appointment letter and identity proof
• Self-certificate of Good Distribution Practice compliance
• Undertaking on storage conditions for the devices to be stocked
• GST registration, where applicable
• Fee payment receipt

The most common problems are a rent agreement in a different name from the applicant, an experience letter from a firm that did not deal in medical devices, and premises details that do not match the GST address. Regovex checks all of these before filing.

The MD 41 form itself is short: it asks for the firm, the premises address, the competent person, the categories of devices you will stock and your storage arrangements. Most rejections happen because the MD 42 license documents required are uploaded in the wrong name or with an old address, not because a document is missing. Keep a single folder with all MD 42 license documents required, signed and scanned in colour, before you start the online form.

How to Apply MD-42 in India: Step-by-Step

To apply for MD-42 in India, you register on ONDLS or your state drug licensing portal, file Form MD-41 with your documents, Good Distribution Practice self-certificate and fee, answer any query, and receive the MD-42 registration certificate from the State Drug Licensing Authority.

1. Eligibility check. Confirm that MD-42 is the right registration for your business and that you do not already hold a license that covers device sales.
2. Appoint the competent person. Choose a graduate, a registered pharmacist, or a 12th-pass person with one year's experience in selling medical devices.
3. Prepare the premises. Arrange storage, temperature control where needed, and areas for expired and returned stock.
4. Register on the portal. Create the applicant account on ONDLS or your state drug licensing portal.
5. File Form MD-41. Enter firm, premises, competent person and storage details exactly as in your documents, and upload them.
6. Pay the government fee online and attach the self-certificate of Good Distribution Practice compliance.
7. Scrutiny and queries. The licensing authority reviews the application and may raise queries or inspect the premises.
8. Grant of MD-42. Once satisfied, the State Drug Licensing Authority grants the registration certificate on Form MD-42.

MD 42 license online apply: where and how to file

The MD 42 license online apply process runs on ONDLS or your state drug licensing portal, the online licensing system used for MD-41 applications in India. You create an applicant account with the firm's email and mobile number, fill the MD 41 form section by section, upload the documents as PDFs, pay the fee online and submit. The portal then shows the file's status, any query raised by the State Drug Licensing Authority and, once granted, the downloadable MD 42 certificate. Keep the login safe: the same account is used later for retention fee payments and change applications. If you find the MD 42 license online apply screens confusing, Regovex can file the application from your account while you approve each step.

Govt. fee for MD-42 and total MD 42 license fees

The govt fee for MD-42 is set in the Second Schedule of the Medical Devices Rules, 2017. Confirm the amount payable on ONDLS or your state drug licensing portal on the day you apply. Regovex quotes its professional fee in writing after the free eligibility check, with the government fee shown separately.

When you budget the total MD 42 license fees, add three things to the govt. fee for MD-42: the cost of setting up compliant storage (racks, a refrigerator and temperature logger if you stock IVD reagents), the competent person's salary or appointment cost, and the professional fee if you use a consultant. For most single-premises distributors, the storage set-up costs more than the government fee itself.

How long does MD-42 take?

The rules do not set a fixed number of days for granting MD-42. In practice, a complete application is often processed within a few weeks, depending on the state's workload and whether the authority inspects the premises. Delays usually come from mismatched documents or a competent person who does not meet the rules, both of which can be fixed before filing.

Mistakes that delay MD-42

• Applying in the name of a person or firm different from the rent agreement or GST registration
• A competent person whose experience was not in selling medical devices
• No storage arrangement for temperature-sensitive IVDs
• Premises not usable for commercial business
• One MD-42 for several premises; each premises needs its own registration

MD 42 License Validity, Retention Fee and Changes

The MD-42 registration certificate remains valid in perpetuity, unless suspended or cancelled, provided the retention fee is paid before five years from the date of issue, and every five years after that. If the retention fee is not paid on time, a late fee applies and the registration can lapse, after which a fresh application is needed.

Report or apply for approval when there is:

• A change of competent person
• A change of ownership, partners or constitution
• A move to a new address, which usually needs a fresh registration
• A new godown or branch, which needs its own registration

Compliance After You Get Your MD-42 Registration

The MD-42 certificate comes with clear conditions. A Medical Devices Officer can inspect the premises and records at any time. The duties that matter most are:

• Buy only from licensed sources: licensed manufacturers, licensed importers, or other registered or licensed dealers
• Keep separate purchase and sale records with device name, batch or lot number, quantity and, where applicable, expiry date
• Retain records for at least two years from the date of the last entry
• Maintain an inspection book in Form MD-43 for the officer's observations
• Store devices correctly, with temperature records for cold-chain items
• Separate expired, damaged and recalled stock, and handle returns and recalls with records
• Display the MD-42 certificate prominently at the premises

Good record-keeping also protects you commercially: hospitals and laboratories increasingly ask distributors for batch traceability and proof of licensed sourcing before placing orders. Regovex helps new MD-42 holders set up simple purchase, sale and recall registers that meet the rules.

The MD 43 inspection register: what to keep at your premises

The MD 43 inspection register is the inspection book in Form MD-43 that every MD-42 holder must keep at the registered premises. When a Medical Devices Officer inspects your shop or godown, the officer records observations, deficiencies and instructions in this register, and you record the action you took. Keep it bound, page-numbered and available during business hours, alongside your purchase and sale records. A missing or blank MD 43 inspection register is one of the first things an officer notices, and Regovex supplies a ready format when your registration is granted.

Good Distribution Practice for Medical Devices: What Your Self-Certificate Means

The MD-41 application includes a self-certificate that you follow Good Distribution Practice. It is a commitment, not a formality, and the licensing authority can check it at any time. In practice it means:

1. Receiving: check each consignment against the invoice, inspect packs for damage, and confirm the supplier's license and the device's labelling before accepting it
2. Storage: store devices as labelled, separate by type and batch, and monitor temperature where needed
3. Stock rotation: issue stock first-expiry-first-out, and check expiry dates regularly
4. Order handling: sell only to buyers entitled to buy, and record each sale with batch or lot details
5. Transport: protect devices in transit, including cold boxes for temperature-sensitive IVDs
6. Returns and recalls: quarantine returned or recalled stock, record it, and handle it as the manufacturer or importer directs
7. Complaints: record complaints and pass them to the manufacturer or importer promptly
8. Training and records: make sure staff know these steps, and keep the records that prove it

Regovex gives every MD-42 client a short Good Distribution Practice checklist and simple register formats, so the self-certificate matches what happens in the shop or godown.

Buying from Licensed Sources: How to Verify Your Suppliers

MD-42 holders must buy devices only from licensed manufacturers, licensed importers, or registered or licensed dealers. Before you add a new supplier, check:

• The manufacturer's license: an MD-5 (Class A or B) or MD-9 (Class C or D) covering the device, or a registration number for a non-sterile, non-measuring Class A device
• The importer's license: an MD-15 import license covering the device, where the device is imported
• The dealer's registration: an MD-42 certificate or a drug license, where you buy from another dealer
• The label: the manufacturer's name and address, license or registration number, batch or lot number and, where applicable, expiry date

Keep copies of these licenses on file. If a device turns out to be unlicensed, the dealer who sold it can face action along with the supplier.

Recalls, Complaints and Adverse Events: The Distributor's Role

When a manufacturer or importer recalls a device or issues a field safety notice, distributors are the link that makes it work. Your sale records tell you which customers received the affected batch, so you can contact them, stop sale and return the stock. Without batch-wise sale records, a recall becomes guesswork.

Distributors should also pass on complaints and reports of adverse events to the manufacturer or importer quickly. India runs a Materiovigilance Programme for reporting adverse events with medical devices, and manufacturers and importers rely on their distribution chain to collect this information.

What the Medical Devices Officer Checks at Inspection

A Medical Devices Officer can inspect MD-42 premises before or after registration. Typical checks in India include:

• The registration certificate displayed and matching the premises
• The competent person present or contactable, with qualification documents
• Storage suited to the devices stocked, including temperature logs for cold-chain items
• Purchase invoices from licensed sources, with copies of supplier licenses
• Separate purchase and sale records with batch or lot numbers and expiry dates
• Expired, damaged and recalled stock kept apart
• The MD-43 inspection book available for the officer's remarks

A short mock check before the first inspection, using this list, removes most avoidable findings.

Starting a Medical Device Distribution Business in India: A Practical Checklist

MD-42 is one step in setting up a device distribution business. In the order most new distributors in India need them:

1. Business set-up: choose the constitution, and register for GST and, if eligible, Udyam
2. Premises: a shop or godown that is legally usable for commercial business, with a rent agreement or ownership deed in the business's name
3. Storage: racks, a refrigerator with a temperature log if you will stock IVD reagents, and a separate area for expired and returned stock
4. Competent person: a graduate, a registered pharmacist, or a 12th-pass person with one year's experience in selling medical devices
5. MD-42 registration: Form MD-41 with the documents, Good Distribution Practice self-certificate and fee
6. Supplier onboarding: distribution agreements or authorisation letters from manufacturers or importers, with copies of their licenses
7. Records: purchase, sale, recall and complaint registers, and the MD-43 inspection book
8. Buyer onboarding: a document pack for hospitals and dealers, with your MD-42 certificate, GST registration and supplier licenses

Regovex can run the regulatory steps of this checklist for you, so you can focus on suppliers and customers.

MD-42 for Multi-State and Multi-Branch Distributors

Because MD-42 is a state registration tied to premises, a distributor with branches in several states needs a certificate from each state where it holds stock or sells from premises. Each branch also needs a qualified competent person and its own records. Distributors that run central billing from one office but dispatch from several godowns should register every godown, because the registration follows the place where devices are stocked.

Regovex runs multi-state MD-42 projects in parallel, with one tracker for all branches, retention dates and competent person changes.

Documents Hospitals and Tenders Ask Device Distributors For

Keeping this pack ready shortens vendor registration with hospitals and helps at technical evaluation in tenders.

Rule Changes to Watch

The Medical Devices Rules are amended regularly. Draft amendments published in December 2025 (G.S.R. 883(E)) proposed changes to inspection and sampling forms and to the validity of certain licenses and registrations subject to retention fees. Regovex tracks such changes and tells MD-42 clients when anything affects their registration, records or fees.

How Regovex Handles Your MD-42 License in India

1. Free eligibility check: do you need MD-42, or does an existing drug license already cover you?
2. Competent person review against the three accepted routes
3. Premises and storage review, including cold chain for IVDs
4. Document checklist in the current format used by the State Drug Licensing Authority
5. Form MD-41 filing on ONDLS or your state drug licensing portal with fee and Good Distribution Practice self-certificate
6. Query replies within 24–48 hours and follow-up until the MD-42 certificate is issued
7. Record-keeping set-up: purchase, sale and recall registers and the MD-43 inspection book
8. After-care: retention fee reminders, change of competent person and new branch registrations

Why Device Distributors in India Choose Regovex

• The whole device supply chain under one roof. We handle MD-42 for distributors, MD-5 and MD-9 for manufacturers, and MD-15 import licenses as your CDSCO registration consultant.
• Drug and device licensing together. As a drug license consultant, we tell you when an existing wholesale or retail drug license already covers your device sales.
• State FDA approval experience with device registrations and inspections across states.
• Multi-branch projects for distributors with several godowns or cities.
• Transparent pricing, with professional and government fees shown separately in writing.
• 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback.

As an MD 42 license consultant, Regovex works only on regulatory filings, so your application is prepared by people who read the Medical Devices Rules every week, not by a general agent. One MD 42 license consultant handles your file from the eligibility check to the certificate, and stays your contact for retention and changes.

MD-42 Services in India and Nearby Areas

Regovex files MD-42 applications for medical device distributors, surgical dealers, diagnostic distributors, equipment suppliers and retailers in India. Documents are collected digitally, applications are filed on ONDLS or your state drug licensing portal, and we support you if the authority inspects the premises.

For an MD 42 license in Uttar Pradesh, the MD-41 application goes to the Food Safety and Drug Administration (FSDA), Uttar Pradesh, through the state's online licensing system, and the premises may be checked by the district's Drug Inspector or Medical Devices Officer. Distributors in Lucknow, Noida, Ghaziabad, Kanpur, Agra, Varanasi and Prayagraj follow the same process, and Regovex prepares the MD 42 license in Uttar Pradesh file with documents in the format the state office expects.

We also serve device businesses in .

Related services:

• Wholesale Drug License in India
• Medical Device Registration in India
• Medical Device Manufacturing License (Class A–D)
• Medical Device Import License (MD-14 / MD-15)
• Retail Pharmacy License in India

What Our Clients Say

"I got my Drug Wholesale License through Regovex Consulting, and Devansh and his team provided complete end-to-end support, from premises selection to timely approval." — Bilal Ahmed Khan, Founder, Medwell Pharma (Drug wholesale and retail licensing)

"Since the product category was relatively new and the guidelines were not very clearly defined, it required additional research and careful interpretation of the regulations." — Parichit Dhawan, Director, Feorah Wellness & Cosmetics

"Got my approval in committed time with complete transparency and zero hassle." — Baburam, Samarpaan Cloud Kitchen (FSSAI food license)

Other clients include Access 2 Healthcare for medical device import licensing.