India imports roughly 70% of the medical devices used in its hospitals and diagnostic centres. From MRI machines and ventilators to surgical instruments and in-vitro diagnostic kits, the dependence on overseas manufacturers remains significant. If you're planning to import medical equipment into India, you'll need to navigate a layered regulatory framework that involves trade licences, health authority approvals, and customs compliance.
Unlike standard industrial goods, medical devices face an additional layer of scrutiny from the Central Drugs Standard Control Organisation (CDSCO). This guide covers the entire medical device import India process, from foundational registrations like IEC and GST to obtaining the CDSCO import license and clearing goods at the port.
Understanding Medical Device Classification in India
Before you begin the import process, you need to determine how your product is classified under India's Medical Device Rules (MDR), 2017. CDSCO follows a risk-based classification system that sorts all medical devices into four categories.
The classification directly affects the type of licence required, the documentation involved, and the review timeline. Class A non-sterile, non-measuring devices follow a simpler registration path. Class C and D devices undergo more rigorous scrutiny, including potential clinical investigation requirements in India.
Foundational Registrations Before You Import Medical Equipment
Several trade and tax registrations must be completed before you apply for any health authority approvals. These form the regulatory backbone of your import operations.
Import Export Code (IEC)
The IEC is a 10-digit number issued by the Directorate General of Foreign Trade (DGFT). It's the primary identity for any entity engaged in cross-border trade in India. Without it, customs won't process your Bill of Entry, and your bank cannot facilitate foreign exchange payments. The application is entirely online and usually processed within 3 to 7 working days. For guided support, you can get help with IEC registration to ensure error-free filing.
GST Registration
Integrated GST (IGST) applies to all goods imported into India, including medical devices. A valid GSTIN is necessary for paying IGST during customs clearance and for claiming input tax credit later. Your GST registration details must match your IEC and PAN records exactly. You can complete the GST registration process online through the government portal.
AD Code Registration on ICEGATE
The Authorized Dealer (AD) Code is a 14-digit number from your bank that connects your current account to the customs system. It's essential for processing foreign exchange remittances. You must register this code on ICEGATE, the electronic gateway of the Central Board of Indirect Taxes and Customs (CBIC). Without an AD Code, you cannot file the Bill of Entry for clearing imported medical devices.
Digital Signature Certificate (DSC)
A Class 3 DSC with signing and encryption capabilities is required for ICEGATE authentication. This is a different type of certificate than the one used for GST or income tax filings. You can apply for your Digital Signature Certificate through a licensed Certifying Authority.
CDSCO Import License: The Health Authority Approval
This is the step that distinguishes medical equipment from ordinary imports. The CDSCO import license is mandatory for all Class A (sterile), Class B, Class C, and Class D medical devices entering India. The process runs through the SUGAM portal, CDSCO's online regulatory submission platform.
Appoint an Indian Authorized Agent
Foreign manufacturers cannot directly apply for a CDSCO licence. They must appoint an Indian entity as their Authorized Agent. This agent must hold either a wholesale drug licence (Form 20B/21B) or a registration certificate in Form MD-42 for selling medical devices in India. The agent acts as the legal point of contact between the manufacturer and CDSCO.
Register on the SUGAM Portal
The Authorized Agent creates an account on the SUGAM portal (sugam.cdsco.gov.in). This portal handles all application submissions, fee payments, query responses, and licence issuance for medical devices.
Submit Form MD-14
Form MD-14 is the official application for an import licence. It requires comprehensive details including the device classification, brand name, intended use, technical specifications, manufacturer details, and regulatory approvals from other countries. Supporting documents include the Free Sale Certificate from the country of origin, ISO 13485 certification, CE marking or US FDA clearance (if available), Device Master File, and product labelling samples.
CDSCO Review and Licence Issuance
CDSCO reviews the submission and may raise queries if the documentation is incomplete. For Class C and D devices without a Free Sale Certificate from the USA, EU, Australia, Canada, or Japan, clinical investigation in India may be required. Once approved, the licence is issued in Form MD-15, valid for five years.
Step-by-Step Import Procedure for Medical Equipment
After securing all registrations and the CDSCO licence, here is the practical flow for bringing medical devices into the country.
Step 1: Identify the HS Code
Medical devices fall under Chapter 90 of the ITC (HS) Code. For example, X-ray machines are classified under HS 9022, while orthopaedic appliances fall under HS 9021. Correct classification determines duty rates and compliance requirements.
Step 2: Place the Order and Arrange Shipping
Negotiate terms with your overseas supplier. Common Incoterms for medical equipment include CIF and DAP. Obtain the proforma invoice, arrange insurance, and coordinate freight logistics. High-value diagnostic machines often require specialized packaging and temperature-controlled containers.
Step 3: Collect Shipping Documents
Your supplier should provide the commercial invoice, packing list, Bill of Lading or Airway Bill, Certificate of Origin, test reports, and the manufacturer's declaration of conformity. Keep the CDSCO import licence (Form MD-15) readily accessible.
Step 4: File the Bill of Entry on ICEGATE
When the shipment arrives at an Indian port, file the Bill of Entry electronically through ICEGATE. Declare the HS code, assessable value, country of origin, and reference the CDSCO licence number. Customs may request a copy of Form MD-15 for verification.
Step 5: Pay Duties and Clear the Goods
Pay the applicable customs duty, IGST, and any surcharges through ICEGATE. Most medical devices attract a basic customs duty between 0% and 10%, with IGST at 12% for many categories. After payment confirmation and document verification, the goods are released for delivery.
Customs Duties on Medical Equipment Imports
Life-saving equipment like pacemakers, cochlear implants, and certain diagnostic devices may attract concessional or nil BCD rates. Devices imported under government health programmes or for research purposes may also qualify for duty exemptions. Always verify the current rate on the CBIC tariff lookup tool before estimating your landed cost.
Documents Required for Medical Equipment Import
Common Challenges and How to Navigate Them
The most frequent hurdle is incorrect device classification. CDSCO's risk-based system is specific, and placing your device in the wrong class can derail the entire application. Refer to CDSCO's notified devices list or consult a regulatory affairs specialist before filing.
Delays in CDSCO approval are another common concern. Applications with incomplete documentation or missing supporting certificates get pushed into query loops. Preparing a thorough dossier upfront, including the Device Master File and all international certifications, minimizes back-and-forth with the authority.
For Class C and D devices from countries outside the five recognized reference markets (USA, EU, Australia, Canada, Japan), CDSCO may require clinical investigation within India. This adds months to the timeline and increases costs. If your device holds approval from any of these five markets, ensure you include the corresponding Free Sale Certificate to avoid this requirement.
