An Import Licence is mandatory if you want to import medical devices into India under the Medical Devices Rules, 2017 (MDR 2017). The licence is granted by the Central Licensing Authority (CLA) under CDSCO in Form MD-15.

This detailed guide covers the complete process — from classification to licence grant — so you can apply correctly and avoid common rejections.

What is an Import Licence for Medical Devices?

An Import Licence allows a company to legally import medical devices (Class A, B, C or D) into India for sale or distribution. Foreign manufacturers must appoint an Authorised Agent in India who applies for the licence on their behalf.

Who Needs an Import Licence?

• Foreign manufacturers of medical devices
• Indian importers / authorised agents
• Companies importing Class A, B, C or D medical devices
• Companies importing In-vitro Diagnostic (IVD) devices

Who Grants the Import Licence?

• Authority: Central Licensing Authority (CDSCO)
• Application Form: Form MD-14
• Licence Issued in: Form MD-15

Step-by-Step Process to Get Import Licence of Medical Devices

Step 1: Confirm Device Classification

Identify whether your device is Class A, B, C or D using the CDSCO Class-wise list and First Schedule of MDR 2017. Classification decides the documentation and scrutiny level.

Step 2: Appoint Authorised Agent in India

Every foreign manufacturer must appoint an Authorised Agent in India through a valid Power of Attorney. The Authorised Agent is responsible for all regulatory communications with CDSCO.

Step 3: Prepare Required Documents

Key documents required for Import Licence application include:

• Covering letter
• Duly filled Form MD-14
• Power of Attorney in favour of Authorised Agent
• Free Sale Certificate from the country of origin (preferably from USA, EU, UK, Canada, Japan or Australia)
• ISO 13485 certificate of the manufacturing site
• Device Master File / Technical documentation
• Plant Master File of overseas manufacturing site
• Labels and Instructions for Use (IFU)
• Essential Principles Checklist
• Undertaking regarding residual shelf life
• Constitution documents of the Authorised Agent
• Fee challan

Step 4: Submit Online Application (Form MD-14)

The Authorised Agent submits the application on the CDSCO online portal along with the prescribed fee.

Step 5: Scrutiny by CDSCO

CDSCO reviews the submitted documents. Queries (if any) are raised and must be replied within the given timeline.

Step 6: Overseas Inspection (if required)

For Class C and Class D devices, CDSCO may conduct an overseas inspection of the manufacturing site. Inspection is usually waived if the device is already approved in regulated markets (USA, EU, UK, Canada, Japan, Australia).

Step 7: Grant of Import Licence

After satisfactory scrutiny (and inspection if applicable), the Central Licensing Authority grants the Import Licence in Form MD-15.

Important Points About Import Licence

• Import Licence is site-specific and product-specific
• Residual shelf life of imported devices must meet the requirements (generally minimum 40% or 50% remaining)
• Licence remains valid in perpetuity subject to retention fee every 5 years
• Any change in constitution, manufacturing site or product requires prior approval or intimation

Common Reasons for Import Licence Rejection

• Incomplete or incorrect documentation
• Missing or invalid Free Sale Certificate
• Improper Power of Attorney
• Non-compliance with residual shelf-life rules
• Incorrect device classification
• Incomplete Device Master File or labels

Import Licence FAQs

Is Import Licence required for all classes of medical devices?

Yes. Import Licence in Form MD-15 is required for Class A, B, C and D medical devices.

Can a foreign manufacturer apply directly?

No. A foreign manufacturer must appoint an Authorised Agent in India who will apply for the Import Licence.

How long does it take to get an Import Licence?

Timeline depends on completeness of documents, class of device and whether overseas inspection is required. With proper documentation, the process is usually faster for devices already approved in regulated markets.

How Satori OCS Can Help You

Obtaining an Import Licence requires accurate documentation, correct classification, and proper coordination with CDSCO.

At Satori One Click Solutions (Satori OCS), we provide end-to-end support for medical device importers and foreign manufacturers, including:

• Device classification support
• Authorised Agent services
• Preparation of complete documentation for Form MD-14
• Free Sale Certificate and Power of Attorney guidance
• Liaison with CDSCO
• Support for residual shelf-life compliance

We have successfully helped multiple clients obtain manufacturing and import licences under MDR 2017.