# Medical Device Licence & Import Registration

> Medical devices in India are regulated under the Medical Devices Rules, 2017 and classified by risk into Class A (low) to Class D (high). Manufacturing licences for Class A and B devices are granted by the State Licensing Authority, and for Class C and D by CDSCO as the Central Licensing Authority. Importers of any class need an import licence from CDSCO. Applications are made on the SUGAM / online medical device portal with the device master file and plant master file.

Practice: Business Licences & Registrations — https://www.industax.com/services/business-licences/

Since the transition period ended in 2023, all classes of medical devices are under licensing, not just the earlier notified list. Getting the classification right is the first and most important step, because it decides the authority, documents, audits and timelines.

We prepare the device master file and plant master file, quality management system evidence (ISO 13485 is expected), labelling, and the application, and coordinate with your notified body or test labs where the class requires audit or testing.

## Key facts

| Item | Detail |
| --- | --- |
| Law | Medical Devices Rules 2017 under the Drugs and Cosmetics Act |
| Classes | A (low) to D (high risk) |
| Class A/B manufacture | State Licensing Authority |
| Class C/D manufacture & all imports | CDSCO (Central Licensing Authority) |
| Key files | Device Master File, Plant Master File, ISO 13485 |

## Who needs this

- Medical device manufacturers
- Importers and distributors of devices and diagnostics
- Foreign manufacturers appointing Indian agents

## What's included

- Classification and regulatory pathway
- DMF and PMF preparation
- Application on the online portal
- Query response and audit support

## Documents

- Device specifications, labels and IFU
- ISO 13485 certificate
- Free sale certificate (imports)
- Power of attorney to the Indian authorised agent (imports)

## Process

1. **Classify** — Risk class and authority identified.
2. **Compile** — Technical files prepared.
3. **Apply** — Application, audit/testing and licence.

## FAQs

### Do Class A medical devices need a licence?

Class A devices are under the licensing framework, but the requirements are lighter than for higher classes, and some low-risk categories have had relaxations notified. We confirm the current position for your specific device before filing.

### Who can apply for an import licence?

An Indian company holding a wholesale drug licence or a manufacturing licence, acting as the authorised agent of the foreign manufacturer under a power of attorney.

### How long does a medical device licence take?

From a few weeks for lower classes to several months for Class C and D, depending on audits, testing and query rounds.

## Official sources

- CDSCO — SUGAM portal: https://cdsco.gov.in/

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Canonical page: https://www.industax.com/services/business-licences/medical-device-registration
Publisher: Indus Tax — CA-led tax and compliance firm (https://www.industax.com). Contact: info@industax.com, 9059139258.
This is general information, not advice for your specific facts.