What is an MD-15 license?

Form MD-15 is the official license issued by CDSCO for the import of medical devices into India.

Who can apply for the import license?

Only an Authorized Indian Representative (AIR) having a valid wholesale drug license can apply on behalf of a foreign firm.

Can one license cover multiple devices?

Yes, an import license can cover multiple devices of the same class from the same manufacturing site.

What is a Free Sale Certificate?

It is a certificate issued by the regulatory authority of the manufacturing country, stating the device is sold freely there.

Is a site inspection mandatory for foreign units?

For Class C and D devices, CDSCO may conduct a physical inspection of the foreign manufacturing site.

How long is the import license valid?

The license is permanent, subject to the payment of license retention fees every 5 years.

Do Class A devices also need a license?

Yes, even Class A (low risk) devices require an import registration, though the process is slightly simpler.

How long does the process take?

The process usually takes 6 to 9 months for a new foreign manufacturing site and device.

Service

Medical Device Import License India

Expert assistance for medical device import licenses. We help with SUGAM portal filing, AIR appointment, and obtaining the MD-15 license for global brands.

Importing Advanced Medical Technology

Expert assistance for medical device import licenses. We help with SUGAM portal filing, AIR appointment, and obtaining the MD-15 license for global brands.

Obtain the mandatory CDSCO Import License (Form MD-15) to legally import and market foreign medical devices in the Indian market.

The gateway for global medical tech. Register with the CDSCO to legally import and sell international medical devices and equipment in India.

The import of medical devices into India is governed by the Medical Devices Rules, 2017. Any person or entity looking to import medical devices must obtain an import license from the Central Licensing Authority (CDSCO). This ensures that the devices used in Indian healthcare are safe, effective, and of high quality.

The registration is granted to an Authorized Indian Representative (AIR) who acts on behalf of the foreign manufacturer. The process involves a detailed review of the foreign manufacturing site's quality standards and the technical specifications of each device being imported.

QuickTaxperts provides specialized regulatory support for international medical device companies, managing the complex documentation, AIR appointment, and the SUGAM portal application process.

Category: Health & Medical
Covers all four classes of devices: Class A, B, C, and D.
Requires a 'Free Sale Certificate' from the national health authority of the home country.
Mandatory compliance with ISO 13485 for the foreign manufacturing unit.
Enables legal supply to hospitals and clinics across India.
Mandatory for all imported medical devices and diagnostics
Registration certificate issued in Form MD-15
Requires a valid Manufacturing License from the home country
Must appoint an Authorized Indian Representative (AIR)

The Authorized Indian Representative (AIR)

Your local partner for CDSCO compliance.

Legal Link: The AIR is the legal point of contact for CDSCO in India for the foreign firm.
License Holder: The Import License (MD-15) is issued in the name of the AIR.
Responsibility: Ensures post-market surveillance and reports any adverse events to the regulator.
Prerequisite: The AIR must have a valid Wholesale Drug License (Form 20B/21B).

Documents required

Document requirements vary by entity type, state, premises, and authority. These are the usual groups we verify before submission.

Import License Checklist: ISO 13485 Certificate of the foreign manufacturing site.; Free Sale Certificate (FSC) from the country of origin.; Plant Master File and Device Master File of the product.; Full list of constituents and technical specifications.; Labels and IFUs (Instructions for Use) in English.; Wholesale Drug License of the Indian Agent (AIR).; Power of Attorney (POA) from the manufacturer to the AIR.

Process and timeline

AIR Appointment: Formalizing the relationship between the foreign firm and the Indian agent.
Document Review: Technical verification of the Device Master File and Site Master File.
Online Filing: Submitting the application on the SUGAM portal (Form MD-14).
CDSCO Review: Responding to technical queries from the CDSCO reviewers regarding the device data.
License Grant: Receiving the official Import License in Form MD-15.

Expert review

Medical Device Import License India content is reviewed by QuickTaxperts Medical Regulatory Team, Import Compliance Specialists.

Checklist-led review
Document pre-verification
Authority-specific next steps

Frequently asked questions

These quick answers cover common planning questions before you request a checklist or quote.

What is an MD-15 license?: Form MD-15 is the official license issued by CDSCO for the import of medical devices into India.
Who can apply for the import license?: Only an Authorized Indian Representative (AIR) having a valid wholesale drug license can apply on behalf of a foreign firm.
Can one license cover multiple devices?: Yes, an import license can cover multiple devices of the same class from the same manufacturing site.
What is a Free Sale Certificate?: It is a certificate issued by the regulatory authority of the manufacturing country, stating the device is sold freely there.
Is a site inspection mandatory for foreign units?: For Class C and D devices, CDSCO may conduct a physical inspection of the foreign manufacturing site.
How long is the import license valid?: The license is permanent, subject to the payment of license retention fees every 5 years.
Do Class A devices also need a license?: Yes, even Class A (low risk) devices require an import registration, though the process is slightly simpler.
How long does the process take?: The process usually takes 6 to 9 months for a new foreign manufacturing site and device.