Licence to Import Medical Device – MD15

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Licence to Import Medical Device

An authorised agent/Importer having licence to manufacture for sale or distribution or wholesale licence for sale or distribution [or registration certificate in Form MD-42], shall make an application for grant of import licence for medical device to the Central Licensing Authority through an CDSCO portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining licence.

Key Indian Medical Device Regulations:

  • The Drugs and Cosmetics Act, 1940 and The Drugs and Cosmetics Rules, 1945
  • Medical Devices Rules, 2017
  • Medical Devices (Amendment) Rules, 2020

The forms required for License to Import Medical Device: 

Applicant Type

Application

License

Importer/ Authorised agent

MD-14

MD-15

 

Fee Structure:

Subject

Fee (in rupees) INR

Import licence for Class A (other than non-sterile and non-measuring) medical device other than in vitro diagnostic medical device for,-

one site

$1000

each distinct medical device

$50

Import licence for Class B medical device other than in vitro diagnostic medical device for,-

one site

$2000

each distinct medical device

$1000

Import licence for Class A (other than non-sterile and non-measuring) or Class B in vitro diagnostic medical device for,-

one site

$1000 

each distinct in vitro diagnostic medical device

$10

Import licence for Class C or Class D medical device other than in vitro diagnostic medical device for,-

one site

$3000

each distinct medical device.

$1500

Import licence for Class C or Class D in vitro diagnostic medical device for,

one site

$3000

each distinct in vitro diagnostic medical device

$500

Inspection of the overseas manufacturing site.

$6000

Import licence retention fee for

one overseas site manufacturing Class A (other than non-sterile and non-measuring) medical device other than in vitro diagnostic medical device; or

$1000

one overseas site manufacturing Class B medical device other than in vitro diagnostic medical device; or

$2000

one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device; or

$3000

each distinct medical device of Class A (other than non-sterile and non-measuring) other than in vitro diagnostic medical device; or

$50

each distinct medical device of Class B other than in vitro diagnostic medical device; or

$1000

each distinct medical device of Class C or Class D other than in vitro diagnostic medical device.

$1500

one overseas site manufacturing Class A (other than non-sterile and non-measuring) or Class B in vitro diagnostic medical device;

$1000

one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device;

$3000

each distinct in vitro diagnostic medical device of Class A (other than non-sterile and non-measuring) or Class B in vitro diagnostic medical device;

$10

each distinct in vitro diagnostic medical device of Class C or Class D in vitro diagnostic medical device;

$500

 

Phases for Import License Registration

Steps for Registration of CDSCO Import License

  1. Determine Classification of Medical Device
    • Check if your device is listed under Notified Medical Devices as per CDSCO classification (Class A, B, C, or D).
  2. Obtain an Indian Authorized Agent (IAA)/ Importer 
    • Foreign manufacturers must appoint an IAA/Importer with a CDSCO registration.
  3. Create an Account on CDSCO SUGAM Portal
    • Register as an importer or authorized agent.
  4. Prepare Documents for Form MD-14 Submission
    • Covering Letter
    • Form MD-14 (Application for Import License)
    • Device Master File (DMF)
    • Plant Master File (PMF)
    • ISO 13485 Certificate
    • Free Sale Certificate (FSC) from the country of origin (duly Notarized)
    • Notarized and Apostilled Power of Attorney
    • Test Reports (if applicable)
    • Undertaking of compliance with MDR 2017 and etc.,
  5. Application Submission via CDSCO Portal
    • Upload documents and complete the application process.
  6. Review and Query Resolution
    • CDSCO may raise queries; timely responses are necessary.
  7. Grant of Import License (Form MD-15)
    • If approved, CDSCO issues Form MD-15, allowing the import of the medical device.

Timeline: 8 – 9 Months (After submission of application on the CDSCO Portal)

Import License Validity: 5 years

Documents Required:

  • Covering Letter
  • Power of Attorney along with undertaking from the authorized agent as per Part I of Fourth Schedule of MDR, 2017
  • Copy of Whole Sale licence / Manufacturing licence / Registration Certificate in Form MD-42 of the Authorized agent
  • Constitution details of the authorized agent
  • Copy of Free Sale Certificate/Marketing Authorization of the product issued by the National Regulatory Authority of country of origin (duly notarized)
  • Copy of Free Sale Certificate Marketing Authorization of the product issued from National Regulatory Authority of any of the following countries viz USA, UK, EU, Canada, Japan or Australia (duly notarized)
  • Copy of overseas manufacturing site /establishment / plant registration (duly notarized)
  • Copy of Certificate supporting Quality Management System (duly notarized)
  • Other Technical Documents required as per checklist

FAQs

  • Can a foreign manufacturer apply directly for an Import License?

No, foreign manufacturers must appoint an Indian Authorized Agent (IAA) who will apply on their behalf.

  • Is a clinical evaluation report (CER) required for an Import License?

For certain high-risk devices (Class C & D) or novel devices, CDSCO may request a CER or clinical investigation data to support safety and performance.

  • Can changes be made to an existing Import License?

Yes, modifications like adding a new product, manufacturer, or legal entity details require submitting a variation application to CDSCO.

How can Medfins help you?

As a regulatory consultant, we assist with the CDSCO Import License process in several ways:

  1. Application Preparation & Submission
  • Classify the medical device as per MDR 2017.
  • Ensure the applicant is registered on the CDSCO SUGAM Portal.
  • Prepare and submit Form MD-14 with all necessary documents.
  1. Documentation Support
  • Assist in compiling the Device Master File (DMF) and Plant Master File (PMF).
  • Review and verify documents like the ISO 13485 certificate, Free Sale Certificate (FSC), test reports, and Power of Attorney.
  • Ensure compliance with Indian regulatory requirements.
  1. Government Fee & Payment Guidance
  • Calculate applicable fees based on device classification.
  • Assist in making the correct fee payment as per the Indian Medical Device Rules, 2017.
  1. Query Handling & CDSCO Liaison
  • Respond to CDSCO queries during the review process.
  • Coordinate with the regulatory authority for smooth approval.
  1. Post-License Compliance
  • Guide on import procedures and customs clearance.
  • Ensure ongoing regulatory compliance, including renewals and amendments.