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September 24, 2026October 12, 2026
CDSCO, Compliance Guides, Import Compliance, Medical Devices

CDSCO Licence for Coronary Stents in India: Class D Registration, Standards and Process

Coronary stents sit at the very top of India’s medical-device risk pyramid. As a permanent, life-sustaining implant placed in the coronary arteries, a stent that fails does not cause an inconvenience — it causes a cardiac event. That is exactly why the Central Drugs Standard Control Organisation (CDSCO) treats coronary stents as a Class D device and reviews them more closely than almost any other product category. This guide walks a manufacturer or importer through the full CDSCO registration pathway for coronary stents under the Medical Devices Rules, 2017 — how they are classified, which licence applies, the standards and clinical evidence expected, the document set, the fees and the realistic timeline.

Is a CDSCO Licence Mandatory for Coronary Stents?

Yes. Coronary stents were among the earliest devices notified and price-capped in India, and under the Medical Devices Rules, 2017 no coronary stent may be manufactured, imported, sold or distributed without a CDSCO licence. There is no de-minimis exemption and no self-declaration route at this class — every bare-metal stent, drug-eluting stent and bioresorbable scaffold needs a licence held either by the Indian manufacturer or, for imports, by the manufacturer through an Indian Authorised Agent. Selling an unlicensed stent is an offence under the Drugs and Cosmetics Act framework that the Rules sit within.

Risk Classification of Coronary Stents

Every medical device in India is placed in one of four risk classes (A, B, C, D) under the First Schedule of the Medical Devices Rules, 2017. The class fixes the authority, the form, the fee, the audit route and the timeline.

Coronary Stents are classified as Class D (high risk). A coronary stent is a long-term implantable device intended to be introduced into the central circulatory system and to remain there, which places it in the highest risk class under the First Schedule. Where a device could fall in two classes the higher class applies, and an accessory is classified in its own right; always confirm against the current CDSCO classification list.

Which CDSCO Licence You Need for Coronary Stents

To manufacture coronary stents in India (Class D) — apply in Form MD-7 to the Central Licensing Authority (CDSCO headquarters); the licence is granted in Form MD-9. A CDSCO joint audit team inspects the manufacturing site before the licence is granted — site inspection is mandatory for Class C and D.
To import coronary stents (any class) — the overseas manufacturer appoints an Indian Authorised Agent who files Form MD-14 with the Central Licensing Authority; the import licence is granted in Form MD-15.
Test licence — for a small quantity imported or made for testing, evaluation, demonstration or clinical investigation: Form MD-12 application, Form MD-13 licence.
Loan licence — using another licensee’s approved premises: Form MD-4 (Class A/B) or Form MD-8 (Class C/D) for a licence in Form MD-6 or MD-10.

Applicable Standards for Coronary Stents

Coronary stents are evaluated against international consensus standards read together with the Essential Principles; drug-eluting stents attract an additional drug dossier. Expect to demonstrate conformity to:

ISO 25539-2 — cardiovascular implants, endovascular devices: vascular stents (design, mechanical testing, corrosion, fatigue and delivery-system performance).
ISO 5832 series — the implantable metals used for the stent platform (e.g. stainless steel, cobalt-chromium).
ISO 10993 series — biological evaluation / biocompatibility of the stent and any polymer coating.
ASTM F2079 / F2477 and equivalent — recoil, radial force and in-vitro characterisation of the stent and balloon.
ISO 11135 / 11137 — validation of the sterilisation process (EO or radiation).
For a drug-eluting stent, the drug component is assessed separately as a drug-device combination, with drug identity, elution profile, stability and pharmacological data.

Documents Required for Coronary Stents CDSCO Licensing

Whether you file for a manufacturing or an import licence, CDSCO expects the same core technical dossier built around the device:

Covering letter and application form — Form MD-3 / MD-7 (manufacture) or Form MD-14 (import) on the CDSCO Medical Device Online portal, stating every device, variant and site.
Device Master File (DMF) — device description and intended use, materials, design and manufacturing information, ISO 14971 risk file, verification/validation data, sterilisation validation where applicable, shelf-life/stability data and the Essential Principles checklist.
Plant Master File (PMF) — site layout, equipment, utilities/HVAC, organisation chart with competent technical staff and the QMS procedures governing production.
ISO 13485 QMS certificate — current, with a scope covering the device.
Essential Principles of Safety and Performance — a completed checklist mapping the device against each applicable principle with the standard/evidence relied on.
Risk management file (ISO 14971) — hazards, risk controls and residual-risk justification.
Test / performance reports — against the applicable BIS/IS or ISO/IEC standards from an accredited laboratory.
Labels, IFU and packaging — meeting the labelling requirements of the Medical Devices Rules (manufacturer, licence number, sterile status, single-use symbols).
Undertaking and declaration of conformity to the Essential Principles and applicable standards.
Government fee receipt — paid online through the CDSCO portal.

Device-specific documents on top of the core set for coronary stents:

Full design and mechanical test reports — radial strength, recoil, fatigue/durability to the labelled cycles, corrosion and delivery-system performance.
Clinical investigation data — pivotal trial results or, where permitted, robust clinical-evaluation evidence and predicate equivalence for the specific stent platform.
Biocompatibility (ISO 10993) reports for the stent, coating and any eluted drug.
Shelf-life and sterilisation validation — real-time and accelerated ageing supporting the stated expiry.
Drug master data (drug-eluting stents) — drug identity, dose per stent, release kinetics, stability and safety.
Country-of-origin approval — US FDA PMA, CE certificate or equivalent for imports, with the Free Sale Certificate.

For an import licence (Form MD-14) there are three further essentials:

Free Sale Certificate (FSC) — from the National Regulatory Authority of the country of origin, legalised (apostille/embassy attestation).
Country-of-origin regulatory approval — US FDA 510(k)/PMA, EU CE certificate or equivalent.
Power of Attorney and Authorised Agent licence — notarised, legalised PoA to the Indian Authorised Agent, plus the agent’s valid wholesale/manufacturing licence.

QMS & Essential Principles — What CDSCO Checks

Essential Principles of Safety and Performance (Fifth Schedule) — the device must be safe and perform as intended, with risks reduced as far as possible; shown through recognised standards and the risk-management file.
Quality Management System (ISO 13485) — design controls, supplier control, process validation, traceability, complaint handling and CAPA, evidenced at audit.
Risk management (ISO 14971) — a living file with residual risks justified and communicated in the IFU.
Clinical evidence — proportionate to the class: clinical evaluation for lower-risk devices and clinical investigation data for many Class C/D and novel devices.

Label & IFU Requirements Specific to Coronary Stents

Stent labelling is scrutinised because the wrong size or expiry reaching a cath-lab is a patient-safety event. Labels and the IFU must carry:

Device name, stent diameter and length, and the exact catalogue/reference number.
Manufacturer name and address, and the CDSCO licence number.
Batch/lot number, date of manufacture and use-by (expiry) date.
“STERILE” with the sterilisation method symbol, and a clear single-use / do-not-reuse symbol.
Storage conditions and MR-safety information where relevant.
For drug-eluting stents, the drug name and dose, and the prescribing/handling information in the IFU.

Bare-Metal vs Drug-Eluting: the Drug-Device Combination Fork

The most important early decision for a coronary stent is whether it carries a drug. A bare-metal stent is regulated purely as a Class D device. A drug-eluting stent is a drug-device combination: the device is licensed under the Medical Devices Rules, but the drug coating brings an additional layer of evaluation — drug identity, elution kinetics, stability and pharmacological safety — and can involve the drug wing of CDSCO. Getting this classification wrong at the outset is the most expensive mistake in the whole file, because it changes the dossier, the reviewers and the timeline. Confirm the combination status before you draft anything else.

Step-by-Step: CDSCO Registration Process

Confirm the classification. Fix the risk class against the CDSCO classification list and the First Schedule — Class D here — which decides the form, authority, fee and audit route.
Choose the route. Manufacture (Form MD-7 → MD-9) or import (Form MD-14 → MD-15). Importers appoint an Indian Authorised Agent holding a valid manufacturing or wholesale licence.
Build the Device Master File and Plant Master File. Assemble device description, materials, design and process data, the ISO 14971 risk file, sterilisation/stability data and the site file with the QMS.
Complete the Essential Principles checklist. Map the device against each applicable essential principle and cite the BIS/IS or ISO/IEC standard or test report relied on.
Draw the test and performance reports. Test to the applicable standards at an accredited laboratory; sterile and measuring devices carry additional validation.
Register and file on the CDSCO Medical Device Online portal. Create the account, pay the government fee online and upload the full dossier under the correct form.
Site audit / inspection. A CDSCO joint audit team inspects the manufacturing site before the licence is granted — site inspection is mandatory for Class C and D.
Respond to queries and receive the licence. Answer the deficiency letter within the stipulated period; on approval the licence issues in Form MD-9 (manufacture) or MD-15 (import).

Government Fees and Timeline

Fees are set in the Second Schedule of the Medical Devices Rules and paid online through the CDSCO portal. For manufacture of a Class D device the fee is Rs 50,000 per site plus Rs 1,000 for each distinct device, paid to the Central Licensing Authority (CDSCO headquarters). Import fees under Form MD-15 are charged per site and per device in USD — roughly USD 1,000 per site plus USD 50 per device for lower-risk devices, up to about USD 3,000 per site plus USD 1,500 per device for Class C and D. A test licence (Form MD-13) carries a modest fee. Always confirm the current figure on the CDSCO portal before filing.

A complete Class D manufacturing file is typically cleared in about six to nine months; an import (MD-15) file usually takes six to nine months. Every deficiency letter effectively restarts the clock. Unlike the old registration certificates, an MDR 2017 licence does not expire — it stays valid as long as the retention fee (equal to the licence fee) is paid every five years and the conditions of licence are met.

Common Mistakes That Trigger a CDSCO Query

Class D files draw the most detailed queries. The recurring reasons coronary-stent applications stall are:

Clinical evidence that does not match the exact stent platform, size range or indication being registered.
Fatigue/durability testing short of the labelled cycle life, or missing corrosion data.
Drug-eluting stents filed as if they were plain devices, with no drug dossier.
Sterilisation or shelf-life validation that does not support the stated expiry.
Free Sale Certificate or country-of-origin approval scope that does not cover every model/size in the application.

Related Approvals to Plan Alongside CDSCO

DGFT Importer-Exporter Code — mandatory for any importer of record before the first consignment.
Wholesale / sale licence (Form 20B/21B or Form MD-42) — for stocking and distributing the device; the Indian Authorised Agent for an import licence must already hold one.
Legal Metrology (LMPC) registration — importers of pre-packaged devices declare MRP, net quantity, importer details and country of origin on the pack.
BIS certification — where the device or its electrical components fall under a mandatory BIS/CRS scheme.
NPPA price ceiling — coronary stents are under price control in India; the ceiling price and trade-margin rules apply to sale even after the CDSCO licence is granted.

Post-Approval Obligations

Print the licence number on the label and keep the Essential Principles conformity current.
Operate a Post-Market Surveillance (PMS) system and file the Periodic Safety Update Report (PSUR) on the schedule for the device’s class.
Report adverse events and field safety corrective actions through the Materiovigilance Programme of India (MvPI) and to CDSCO within the prescribed timelines.
Report any change in device, materials, site, labelling or QMS, and any regulatory action or recall in another country.
Retain distribution records for traceability and allow CDSCO to draw samples and inspect the premises.
Pay the retention fee every five years to keep the licence in force, and track BIS/ISO standard revisions.

Frequently Asked Questions

What risk class is a coronary stent under CDSCO?

A coronary stent is Class D — the highest risk class — because it is a long-term implant in the central circulatory system. That routes a domestic manufacturer to Form MD-9 with the Central Licensing Authority and an importer to Form MD-15.

Do I need clinical trial data to register a coronary stent?

For a Class D implant, yes — CDSCO expects clinical investigation data or, where accepted, strong clinical-evaluation and equivalence evidence for the specific stent platform, not just bench testing.

Is a drug-eluting stent treated differently from a bare-metal stent?

Yes. A drug-eluting stent is a drug-device combination, so on top of the Class D device dossier you must provide drug identity, dose, elution profile, stability and pharmacological safety data.

Which licence do importers of coronary stents need?

Importers register through an Indian Authorised Agent who files Form MD-14 with the Central Licensing Authority; the import licence is granted in Form MD-15, supported by the Free Sale Certificate and country-of-origin approval.

How long does coronary stent registration take?

For a Class D device, budget roughly six to nine months for a manufacturing (MD-9) or import (MD-15) licence once a complete dossier is filed, longer if clinical data or drug information triggers additional review.

Are coronary stents price-controlled in India?

Yes. Separately from the CDSCO licence, coronary stents fall under NPPA price control, so the ceiling price and trade-margin rules govern how the licensed stent may be sold.

Why Choose PCN India Global

Classification triage — we confirm the correct risk class for your coronary stents against the current CDSCO list before anything is drafted.
Route selection — manufacture (MD-5/MD-9) or import (MD-15), with the Indian Authorised Agent arrangement handled.
Dossier build — Device Master File, Plant Master File, Essential Principles checklist and ISO 13485/ISO 14971 readiness.
Standards and testing — the right BIS/IS or ISO/IEC standards mapped and accredited test reports coordinated.
End-to-end online filing — application, audit support, query response and the licence grant managed for you.
Adjacent approvals — DGFT/IEC, LMPC, wholesale/sale licence and BIS coordinated alongside your CDSCO licence.

PCN India Global manages the complete CDSCO process for coronary stents — from classification and route selection to Device and Plant Master File preparation, online filing, audit support and the licence grant. WhatsApp or call +91 80109 05029, or email admin@pcnindiaglobal.com, to get your registration underway.

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