MD-42 Registration for Medical Device Sale and Distribution

MD-42 registration is the certificate that allows a business to sell, stock, exhibit, offer for sale or distribute medical devices, including IVDs, in India. Medfins International, which holds its own MD-42 registration, helps distributors, traders, retailers and importers prepare the MD-41 application, meet premises and record-keeping conditions, and stay compliant after the certificate is issued.

What is MD-42 registration?

An amendment to the Medical Devices Rules, 2017 in 2022 brought the sale and distribution of medical devices under a dedicated registration system. A business applies in Form MD-41 and, once approved, receives a registration certificate in Form MD-42 to sell, stock, exhibit or offer for sale or distribute medical devices, including in vitro diagnostic devices.

The certificate is issued by the State Licensing Authority for the premises concerned. MD-42 registration is often described informally as a medical device wholesale licence, and it is the most common licence held by device distributors that do not already hold a drug sale licence.

Who needs MD-42 registration?

• Distributors, stockists and wholesalers of medical devices and IVDs.
• Traders and dealers supplying hospitals, clinics, laboratories and government buyers.
• Retailers and showrooms that stock or display devices for sale.
• Indian companies that want to act as the authorised agent of an overseas manufacturer, since CDSCO accepts MD-42 as one of the licences an agent can hold for an MD-15 import licence.
• E-commerce and institutional suppliers that hold stock of devices in India.

Businesses that already hold a sale licence under the Drugs Rules, 1945 covering the relevant activity may not need a separate MD-42 certificate. Because this depends on the licence held and the activity, we confirm the position for each client before filing.

Scope of the registration

The registration relates to premises and activity rather than to individual devices. It covers devices of all risk classes, but it does not replace the manufacturer’s or importer’s product licence. Every device you buy and sell must come from a licensed manufacturer or importer, and you should keep evidence of this.

How MD-42 fits with other licences

Many businesses hold MD-42 alongside other approvals. Understanding which licence covers which activity avoids gaps:

• MD-42 registration: selling, stocking, exhibiting and distributing devices from registered premises.
• Import licence (MD-15): bringing a foreign manufacturer’s devices into India, held by the authorised agent.
• Manufacturing licence (MD-5 or MD-9): making devices in India. A licensed manufacturer can generally sell its own products without a separate MD-42.
• Test licence (MD-13 or MD-17): samples for testing or evaluation only, never for sale.

A distributor that also wants to import usually needs MD-42 first and then the import licence, so the order of applications matters.

Documents required

Requirements can vary slightly between states, but an MD-41 application usually includes:

• Application in Form MD-41 with proof of fee payment.
• Constitution documents of the business (partnership deed, incorporation certificate, LLP agreement or proprietorship proof).
• Proof of ownership or tenancy of the premises and a site plan.
• Details of storage arrangements, including temperature control where devices require it.
• Details of the competent person responsible for the business, with qualification and experience documents.
• Identity and address proof of the proprietor, partners or directors.
• Declarations and undertakings as required by the State Licensing Authority.

Step-by-step process

1. Eligibility check: confirm whether MD-42 is required or whether an existing licence already covers your activity.
2. Premises readiness: storage space, environmental controls and area segregation where needed.
3. Document preparation: constitution, premises, competent person and declarations.
4. Online application in Form MD-41 with the prescribed fee.
5. Scrutiny and, where required, inspection by the State Licensing Authority or its officers.
6. Query response and submission of any additional documents.
7. Grant of MD-42 and set-up of purchase, sale and storage records.

Fees, validity and conditions

As per the amended rules, the fee is typically INR 3,000, and the certificate remains valid provided a retention fee is paid every five years. We confirm the current fee before you file. Holders must comply with conditions that typically include:

• Displaying the certificate at the premises.
• Storing devices as specified by the manufacturer.
• Buying only from licensed manufacturers, importers or registered dealers.
• Keeping purchase and sale records, including batch or lot details, for the period required.
• Allowing inspection and sampling by Medical Device Officers.

Timelines and what affects them

The time to receive MD-42 registration depends largely on the state, the completeness of the application and whether an inspection is scheduled. Applications with clear premises documents and a well-qualified competent person generally move faster. Delays usually come from missing documents rather than from the review itself. Preparing the premises and records before filing is the most reliable way to avoid repeat queries.

Common reasons for queries and delays

• Premises documents that do not match the address in the application.
• Competent person documents that are incomplete or do not meet the criteria.
• No storage arrangements for temperature-sensitive devices or IVD reagents.
• Applying for MD-42 when an existing drug licence already covers the activity, or the reverse.
• Weak record-keeping discovered during inspection after grant.

How Medfins International supports you

Medfins International holds its own CDSCO MD-42 registration, so we know the application and the day-to-day conditions from direct experience. Our support includes:

• Checking whether MD-42 is needed for your business model.
• Reviewing premises, storage and records before filing.
• Preparing and filing the MD-41 application and handling queries.
• Setting up simple purchase, sale and traceability records.
• Helping you move on to government supply through GeM registration.

To start your application, contact our team with your premises details and the devices you plan to handle.

Frequently asked questions