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

CDSCO Licence for Contact Lenses in India: Class B Registration, ISO 18369 and Process

A contact lens sits directly on the eye’s surface, correcting vision or changing appearance — and even a plano coloured lens is a medical device because of where it goes. CDSCO regulates contact lenses as a Class B device with the ophthalmic-optics contact-lens standard series and biocompatibility behind the licence. This guide covers the full CDSCO registration pathway for contact lenses under the Medical Devices Rules, 2017 — classification, licence route, ISO 18369, the documents, the fees and the timeline. (Contact lens care solutions are a related, separately registered product.)

Is a CDSCO Licence Mandatory for Contact Lenses?

Yes. A contact lens is a notified Class B medical device and cannot be manufactured, imported or sold in India without a CDSCO licence — this includes non-corrective (plano) coloured and cosmetic lenses. A domestic manufacturer holds a Form MD-5 licence from the State Licensing Authority; an importer holds a Form MD-15 import licence through an Indian Authorised Agent. Daily, monthly, toric, multifocal and coloured lenses fall within the framework.

Risk Classification of Contact Lenses

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.

Contact Lenses are classified as Class B (low-to-moderate risk). A contact lens is a device in prolonged contact with the eye surface, where material and hygiene issues carry an ocular-health risk, placing it in Class B (low-to-moderate 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 Contact Lenses

To manufacture contact lenses in India (Class B) — apply in Form MD-3 to the State Licensing Authority (SLA); the licence is granted in Form MD-5. A CDSCO-empanelled Notified Body audits the site. For Class A the audit is post-grant; for Class B it is carried out before the licence is granted.
To import contact lenses (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 Contact Lenses

Contact lenses are evaluated against the ophthalmic-optics contact-lens standard series plus biocompatibility:

ISO 18369 series — ophthalmic optics: contact lenses (vocabulary, tolerances, measurement and material designation).
ISO 18369-4 — physicochemical properties of contact-lens materials.
ISO 9394 — biocompatibility: evaluation of contact lenses and lens-care products by ocular study.
ISO 10993 series — supporting biological evaluation of the lens material.
ISO 11135 / 11137 — sterilisation validation for sterile lenses.
Oxygen-permeability (Dk/t) and dimensional data as required by the standard.

Documents Required for Contact Lenses 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 contact lenses:

ISO 18369 test reports — power, dimensions, oxygen permeability (Dk/t) and material properties.
Biocompatibility (ISO 9394 / ISO 10993) for the lens material and, for coloured lenses, the pigments.
Colour-additive safety and leaching data for coloured/cosmetic lenses.
Sterilisation and shelf-life validation supporting the expiry.
Recommended wear/replacement schedule justification.
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 Contact Lenses

Contact-lens labelling is checked for power, material and hygiene information:

Power (dioptres), base curve, diameter and, for toric, cylinder/axis, with the reference number.
Manufacturer name and address, and the CDSCO licence number.
Batch/lot number, date of manufacture and use-by date.
“STERILE” with the sterilisation-method symbol and a single-use (or replacement-schedule) symbol.
Wear/replacement schedule and hygiene warnings in the IFU.

Coloured & Cosmetic Lenses Are Not Exempt

A persistent misconception is that non-corrective coloured or “cosmetic” contact lenses are a beauty accessory rather than a medical device. They are not: because they sit on the eye, plano coloured and cosmetic lenses are Class B medical devices and need a CDSCO licence, with additional evidence for the colour additives and their leaching. Register the full range you sell — corrective and cosmetic — and evidence the pigments for coloured lenses. Treating cosmetic lenses as unregulated is a compliance and safety failure.

Step-by-Step: CDSCO Registration Process

Confirm the classification. Fix the risk class against the CDSCO classification list and the First Schedule — Class B here — which decides the form, authority, fee and audit route.
Choose the route. Manufacture (Form MD-3 → MD-5) 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-empanelled Notified Body audits the site. For Class A the audit is post-grant; for Class B it is carried out before the licence is granted.
Respond to queries and receive the licence. Answer the deficiency letter within the stipulated period; on approval the licence issues in Form MD-5 (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 B device the fee is Rs 5,000 per site plus Rs 500 for each distinct device, paid to the State Licensing Authority (SLA). 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 B manufacturing file is typically cleared in about three to six 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

Common query reasons for contact-lens applications are:

Oxygen-permeability (Dk/t) or material data missing.
Coloured lenses without pigment-safety and leaching data.
Biocompatibility not covering the wear duration/material.
Sterilisation validation absent for sterile lenses.
Free Sale Certificate scope not covering all powers/variants 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.

Frequently Asked Questions

What CDSCO class is a contact lens?

A contact lens is Class B, including non-corrective coloured lenses. A domestic manufacturer files Form MD-3 for an MD-5 licence; an importer files Form MD-14 for an MD-15 licence.

Are coloured/cosmetic contact lenses regulated?

Yes — plano coloured and cosmetic lenses are Class B medical devices and need a CDSCO licence, with extra evidence for the colour additives and their leaching.

Which standard applies to contact lenses in India?

The ISO 18369 series for contact lenses, with ISO 9394/ISO 10993 biocompatibility and validated sterilisation for sterile lenses.

Is a factory audit required?

Yes — for Class B manufacture a CDSCO-empanelled Notified Body audits the site before the MD-5 licence is granted.

How long does contact-lens registration take?

A complete Class B manufacturing (MD-5) file is usually cleared in about three to six months; an import (MD-15) file typically takes six to nine months.

Does the licence expire?

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

Why Choose PCN India Global

Classification triage — we confirm the correct risk class for your contact lenses 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 contact lenses — 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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