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September 30, 2026October 12, 2026
CDSCO, Compliance Guides, Import Compliance, Medical Devices

CDSCO Licence for Endoscopes in India: Class C Registration, ISO 8600 and Process

An endoscope lets a clinician see inside the body — the GI tract, airways, joints or abdomen — and often carries instruments to treat what it finds. Because it is an invasive device that contacts internal tissue and is usually reused, CDSCO regulates the endoscope as a Class C device with the endoscope standard, biocompatibility and reprocessing validation behind the licence. This guide covers the full CDSCO registration pathway for endoscopes under the Medical Devices Rules, 2017 — classification, licence route, ISO 8600, the documents, the fees and the timeline. This guide explains CDSCO registration for endoscopes in India — risk class, licence forms, standards, documents, fees and timeline.

Is a CDSCO Registration Mandatory for Endoscopes?

Yes. An endoscope is a notified Class C medical device and cannot be manufactured, imported or sold in India without a CDSCO licence. Because it is Class C, a domestic manufacturer applies to the Central Licensing Authority in Form MD-7 for a Form MD-9 licence. An importer applies in Form MD-14 for a Form MD-15 import licence. Flexible and rigid endoscopes, and their light sources and processors, are declared with the system.

Risk Classification of Endoscopes

Every medical device in India falls into 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.

Endoscopes are classified as Class C (moderate-to-high risk). An endoscope is a surgically invasive device that contacts internal tissue, typically reused, where inadequate reprocessing carries a cross-infection risk, placing it in Class C (moderate-to-high risk) 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 Endoscopes

To manufacture endoscopes in India (Class C) — apply in Form MD-7 to the Central Licensing Authority (CDSCO headquarters). The licensing authority grants the licence in Form MD-9. A CDSCO joint audit team inspects the manufacturing site before the licensing authority grants the licence — site inspection is mandatory for Class C and D.
To import endoscopes (any class) — the overseas manufacturer appoints an Indian Authorised Agent who files Form MD-14 with the Central Licensing Authority; CDSCO grants the import licence 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 Endoscopes

Endoscopes are evaluated against the endoscope standard plus biocompatibility and reprocessing:

ISO 8600 series — optics and photonics: medical endoscopes and endotherapy devices.
ISO 10993 series — biocompatibility of patient-contacting components.
ISO 17664 — information supplied by the manufacturer for the processing of medical devices (reprocessing validation).
IEC 60601-1 / -1-2 — where the endoscope system includes electrical equipment (light source/processor).
IEC 60601-2-18 — endoscopic equipment, where applicable.
Sterilisation / high-level-disinfection validation for reusable endoscopes.

Documents Required for CDSCO Registration of Endoscopes

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 for Endoscopes

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

ISO 8600 performance reports — optical performance, field of view and mechanical integrity.
Reprocessing validation (ISO 17664) — cleaning, disinfection and sterilisation instructions and evidence.
Biocompatibility (ISO 10993) for patient-contacting parts.
Electrical-safety / EMC evidence for the light source and processor.
Channel-integrity and leak-test data for flexible endoscopes.
Country-of-origin approval and Free Sale Certificate for imports.

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 Endoscopes

Endoscope labelling and the IFU are checked for type, reprocessing and compatibility:

Device name, type (flexible/rigid), working length and channel details.
Manufacturer name and address, and the CDSCO licence number.
Batch/serial identification and the date of manufacture.
Reusable/single-use status and the validated reprocessing method.
Compatible light source/processor and endotherapy accessories in the IFU.

Reprocessing Is the Core Risk

The defining risk for a reusable endoscope is cross-infection from inadequate reprocessing — a recurring theme in device-safety alerts worldwide. CDSCO expects validated cleaning, disinfection and, where applicable, sterilisation instructions (ISO 17664) that a hospital can actually follow, plus channel-integrity and leak-test evidence for flexible scopes. Single-use endoscopes sidestep reprocessing but need their own sterility evidence. Decide reusable vs single-use and get the reprocessing validation right — it is the make-or-break of an endoscope file.

Step-by-Step CDSCO Registration Process for Endoscopes

Confirm the classification. Fix the risk class against the CDSCO classification list and the First Schedule — Class C 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 licensing authority grants the licence — 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).

CDSCO Registration Fees and Timeline for Endoscopes

The Second Schedule of the Medical Devices Rules sets the fees, and you pay them online through the CDSCO portal. For manufacture of a Class C 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). CDSCO charges import fees under Form MD-15 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 C manufacturing file typically clears 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 you pay the retention fee (equal to the licence fee) every five years and meet the conditions of licence.

Common Mistakes That Trigger a CDSCO Query

For Class C reusable invasive devices, the recurring query reasons are:

Reprocessing instructions not validated (ISO 17664) or not hospital-executable.
Channel-integrity/leak-test data missing for flexible endoscopes.
Biocompatibility not covering all patient-contacting parts.
Electrical-safety evidence absent for the light source/processor.
Free Sale Certificate scope not covering the system on import.

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.

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.

FAQs on CDSCO Registration for Endoscopes

What CDSCO class is an endoscope?

An endoscope is Class C, so a domestic manufacturer files Form MD-7 for an MD-9 licence with the Central Licensing Authority, and an importer files Form MD-14 for an MD-15 licence.

Which standard applies to endoscopes in India?

The ISO 8600 series for medical endoscopes, with ISO 17664 reprocessing validation, ISO 10993 biocompatibility and electrical-safety evidence for the light source/processor.

Why is reprocessing so important?

Reusable endoscopes carry a cross-infection risk if not properly reprocessed, so CDSCO expects validated, executable cleaning/disinfection/sterilisation instructions.

Does CDSCO require a site inspection?

Yes — for Class C manufacture, a CDSCO joint audit team inspects the site before the licensing authority grants the MD-9 licence.

How long does endoscope registration take?

Budget roughly six to nine months for a complete Class C manufacturing (MD-9) or import (MD-15) file.

Does the licence expire?

No — the MDR 2017 licence is perpetual, subject to the five-yearly retention fee and continued compliance.

Related CDSCO Registration Guides

Need end-to-end help? See our CDSCO registration services, or read these related guides:

Official references: Central Drugs Standard Control Organisation (CDSCO) and the CDSCO MD Online portal.

Why Choose PCN India Global

Classification triage — we confirm the correct risk class for your endoscopes against the current CDSCO list before we draft anything.
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 endoscopes — 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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