Drug Licence for Medical Devices in India 2026 | Process & Requirements

If your company plans to manufacture, import or distribute medical devices in India regulatory compliance is not optional

Since 2026 the rules for medical devices have become stricter. Authorities are now paying more attention to the safety, quality and traceability of devices than they did before

You cannot simply start selling a device and apply later. The license must come first

Before you can sell your device in India, you need to get a drug license under the Medical Device Rules if it falls into the regulated category. A lot of new businesses and importers forget to do this step early on in their planning. That mistake often causes shipments to be late, products to be taken or notices from the government

Read More How to Download a Drug License in India in 2026

When You Actually Need a Drug License for Medical Devices

The first thing you must determine is whether your product qualifies as a medical device under Indian law

India regulates medical devices under the Medical Device Rules 2017. These rules classify devices based on risk level

Your product may fall into one of four classes:

• Class A – Whether it is low risk
• Class B – It is Low-moderate risk
• Class C – It is Moderate-high risk
• Class D – High risk

For example, products such as thermometers, blood pressure monitors, implants, diagnostic kits or surgical instruments are usually regulated

If your device appears in the notified device list, you must obtain a license before selling it in India

The exact license type depends on what your company does

• Manufacturing devices in India requires a manufacturing license.
• Importing devices requires an import license.
• Distributing devices may require a wholesale drug license.

Many companies discover too late that even software-based medical devices or diagnostic kits require regulatory approval

That is why classification should always be your first step

Regulatory Authorities and the Governing Framework

Medical device licensing in India operates under a central regulatory system

The main authority responsible for approval is the Central Drugs Standard Control Organization

Within CDSCO, approvals are handled through the online portal called SUGAM Portal

However, depending on the device classification, you may deal with two different regulators:

• State Licensing Authorities (SLA) for Class A and B devices
• CDSCO Headquarters for Class C and D devices

Step-by-Step Process to Obtain the License

The licensing process follows a structured pathway. Each stage requires careful preparation

Step 1: Classification of Medical Devices

Before filing any application confirm the device classification under the Medical Device Rules

• Risk class
• Intention of use
• Applicable regulatory pathway

Classification mistakes are surprisingly common. If you submit the wrong category, your application will simply be returned

Step 2: Prepare Technical Documentation

Your next task is building the technical file for the device

This documentation proves that your product is safe and performs as intended

Your file normally includes:

• Device description
• Intended use statement
• Risk analysis report of devices
• Clinical evidence (if applicable)
• Details of Medical Devices’ Manufacturing process 
• Quality management certification

If your company manufactures devices authorities will also check whether your facility follows ISO 13485

Step 3: CCDSCO SUGAM Portal Registration

All applications must be submitted through the CDSCO online system

You will create a company account, upload documents and select the correct application form

Different activities require different forms.

For example:

• MD-14 / MD-15 – Import license
• MD-3 / MD-5 – Manufacturing license for Class A and B
• MD-7 / MD-9 – Manufacturing license for Class C and D

Step 4: Authority Review and Queries

After submission the regulator reviews your application

This stage involves technical scrutiny. Officers evaluate whether your device meets safety, performance, and quality requirements.

If something is unclear you will receive a query letter

You must respond within the specified time. Ignoring queries or submitting incomplete replies often results in rejection

Most delays happen during this phase

Step 5: Inspection of Medical Devices

For manufacturing licenses, regulatory authorities may inspect your facility. Check:

• Equipment calibration
• Records of each batch
• Complaint handling procedures

This inspection verifies that your facility actually follows the standards described in your documents

If gaps appear during inspection the authority may ask for corrective actions

Step 6: Grant of Drug License for Medical Devices

Once the authority completes its evaluation, your license is issued through the SUGAM portal

You can then legally manufacture, import, or distribute the medical device in India

But approval does not end your compliance responsibilities

You must continue to maintain quality systems, report adverse events and renew licenses as required

Read More Documents Required for Wholesale Drug License in India

Wrapping Up

Obtaining a drug license for medical devices in India requires planning, documentation and patience

You begin with classification under the Medical Device Rules. Then you prepare the technical file, submit the application through the CDSCO portal, respond to regulatory queries and undergo inspection if required

Once approved your license allows you to legally manufacture or import devices in the Indian market

But the process works smoothly only when your preparation is thorough. Contact Agile Regulatory for expert help.