Medical Device Distributor License in India Registration Process

Medical Device Distributor License in India Registration Process

If you are planning to distribute medical devices in India, not manufacture them, not import them directly, just store and sell them, you still fall under regulation. Many people miss this point and assume distribution is informal. It isn’t anymore.

India’s medical device rules now clearly say that anyone who sells, stocks, exhibits or distributes medical devices must be registered with the licensing authority. This applies even if you are only operating at a local or regional level

So before you rent a warehouse or sign distributor agreements you need to understand how the distributor license works, what form applies and what regulators actually expect from you in 2026

Why distribution is regulated now?

Medical devices are no longer treated as a side category of drugs. Since the notification of the Medical Devices Rules 2017 under the Drugs and Cosmetics Act 1940 the government has been tightening control across the entire supply chain

That includes manufacturers, importers and yes distributors

The logic is simple. Devices can cause harm if stored incorrectly, sold without traceability or handled by untrained personnel. Regulation at the distribution level is meant to prevent that

The law that applies to you

Your distributor registration comes under the Medical Devices Rules 2017. These rules are enforced by State Licensing Authorities with overall oversight by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare

You are not applying for a “drug license” for devices anymore. That older route has been phased out for medical devices.

Read More Medical Device Manufacturing License Registration in India (2026 Update)

The exact license you need

As a distributor, wholesaler or retailer of medical devices you must obtain a Registration Certificate in Form MD-42

To get that certificate you submit an application in Form MD-41

This registration allows you to:

• Sell
• Stock
• Exhibit
• Distribute

medical devices and in-vitro diagnostic devices in India.

Without MD-42, distribution is considered unauthorized.

Who issues the distributor license

Unlike manufacturing licenses for higher-risk devices, distributor registrations are handled at the state level.

You apply to the State Licensing Authority where your business premises are located. The state authority reviews your documents, may inspect your premises, and then issues MD-42 if everything is acceptable.

Who can apply

You must be a legally recognized business entity in India. That can be a proprietorship, partnership, LLP, or company. There is no restriction on business structure, but you must have a physical premises used for storage and distribution.

Virtual addresses do not work here.

One requirement people often overlook: technical staff

Every distributor must appoint Competent Technical Staff (CTS). This is not optional.

The CTS is responsible for overseeing storage, handling, and distribution activities. Regulators look closely at this person’s qualifications.

The CTS can be:

• a registered pharmacist, or
• a person with a degree or diploma in a relevant discipline, or
• someone who has passed an intermediate examination and has at least one year of relevant experience

If you do not clearly demonstrate this in your application approval will stall

Documents you will need

The list is not complicated, but accuracy matters.

You typically submit:

• business registration documents
• proof of premises ownership or rent agreement
• layout details of the storage area
• identity and qualification proof of the CTS
• self-declaration of compliance with Medical Devices Rules

Authorities are less forgiving now than they were a few years ago. Inconsistent addresses, unclear CTS roles or missing signatures often trigger objections

How the application is filed

You complete Form MD-41 and submit it to the State Licensing Authority, usually through the designated online system or as notified by the state.

You also pay the government fee specified in the Second Schedule of the Medical Devices Rules.

Once submitted, the authority reviews your application. If documents are clear and complete, the process moves fast. If not, queries are raised.

Read More Medical Device Registration

Inspection is common, not rare

Many states conduct a physical inspection before issuing MD-42.

The inspecting officer checks:

• Storage conditions
• Record-keeping
• Availability of the CTS
• Basic compliance with distribution practices

This is not meant to intimidate you. It is meant to confirm that what you declared actually exists

Validity of the license

The MD-42 registration certificate does not expire annually. However you must pay a retention fee every five years to keep it valid

Missing the retention timeline can lead to cancellation. This happens more often than people think

Your responsibilities after approval

Once licensed, you must:

• Maintain purchase and sale records
• Ensure devices are sourced only from licensed manufacturers or importers
• Inform the authority if your premises or CTS changes
• Allow inspections when required

A distributor is part of the regulated chain, not outside it.

Conclusion

If you plan to distribute medical devices in India registration under Form MD-42 is mandatory. The process is not difficult but it does require attention to detail and an understanding of what regulators expect in real terms

If you want to avoid delays and move forward with confidence working with Agile Regulatory can make the process smoother and more predictable