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October 10, 2026October 12, 2026
CDSCO, Compliance Guides, Import Compliance, Medical Devices

CDSCO Licence for Surgical Gloves in India: Class B Registration, IS 4148 and Process

Q: What CDSCO class are surgical gloves?

Sterile surgical gloves are Class B. A domestic manufacturer files Form MD-3 for an MD-5 licence from the State Licensing Authority; an importer files Form MD-14 for an MD-15 licence.

Sterile surgical gloves are a barrier between a clinician’s hands and a patient’s open surgical field, so their integrity is a patient-safety matter, not a comfort feature. Also, CDSCO regulates surgical gloves as a Class B medical device with a defined Indian Standard, sterility assurance and acceptable-quality-level (AQL) testing for pinholes. This guide covers the full CDSCO pathway for surgical gloves under the Medical Devices Rules, 2017 — classification, licence route, IS 4148 and ISO 10282, the documents, the fees and the timeline. (Non-sterile examination gloves follow the same framework at a slightly different profile.) This guide explains CDSCO registration for surgical gloves in India — risk class, licence forms, standards, documents, fees and timeline.

Is a CDSCO Registration Mandatory for Surgical Gloves?

Yes. In fact, surgical gloves are a notified Class B medical device and cannot be manufactured, imported or sold in India without a CDSCO licence. A domestic manufacturer holds a Form MD-5 licence from the State Licensing Authority. Furthermore, an importer holds a Form MD-15 import licence through an Indian Authorised Agent. Latex and synthetic (nitrile/polyisoprene) surgical gloves are covered under the same route, with the material and any powder declared.

Risk Classification of Surgical Gloves

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. Also, the class fixes the authority, the form, the fee, the audit route and the timeline.

Moreover, surgical gloves are classified as Class B (low-to-moderate risk). A surgical glove is a sterile, single-use device that contacts breached skin and internal tissue during surgery, placing it in Class B under the First Schedule. In addition, 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 Surgical Gloves

To manufacture surgical gloves in India (Class B) — apply in Form MD-3 to the State Licensing Authority (SLA). The licensing authority grants the licence in Form MD-5. A CDSCO-empanelled Notified Body audits the site. For Class A the audit is post-grant. For Class B the Notified Body conducts it before the licensing authority grants the licence.
To import surgical gloves (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 Surgical Gloves

Surgical gloves have Indian Standards and are checked against them plus sterility and biocompatibility:

IS 4148 — rubber surgical gloves (dimensions, tensile strength, freedom from holes / AQL, sterility).
ISO 10282 — single-use sterile rubber surgical gloves (international equivalent for imports).
IS 15354 / ISO 11193 — single-use examination gloves, where examination gloves are also registered.
ISO 11135 / 11137 — sterilisation validation for sterile surgical gloves.
ISO 10993 series — biocompatibility, including sensitisation for latex proteins and chemical accelerators.
ASTM D3577 and equivalents — often cited for imported surgical gloves.

Documents Required for CDSCO Registration of Surgical Gloves

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 (manufacture) or Form MD-14 (import) on the CDSCO Medical Device Online (SUGAM) 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 Surgical Gloves

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

IS 4148 / ISO 10282 test reports — watertightness/AQL for pinholes, tensile properties before and after ageing, dimensions.
Sterilisation validation for sterile gloves, with the sterility assurance level.
Biocompatibility and protein-content data for latex gloves (to manage sensitisation risk).
Powder status declaration — powdered vs powder-free, with residual-powder limits if powdered.
Shelf-life / stability data supporting the expiry.

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 Surgical Gloves

Glove labelling is checked for size, sterility and material messaging:

Glove size, material (latex / nitrile / polyisoprene) and “powder-free” or powder status.
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 for surgical gloves, or “non-sterile” for examination gloves.
A single-use symbol and, for latex, a caution regarding natural-rubber-latex allergy.

Surgical vs Examination Gloves: Different Products, Same Framework

Surgical gloves and examination gloves are frequently confused, but they are different devices. Also, surgical gloves are sterile, anatomically sized and used in the surgical field (IS 4148 / ISO 10282). Examination gloves are usually non-sterile, ambidextrous and used for general clinical protection (IS 15354 / ISO 11193). Both are regulated devices, but the standard, sterility profile and often the risk class differ. Additionally, decide which product you are registering and cite the correct standard — mixing the two in one dossier is a common cause of queries.

Step-by-Step CDSCO Registration Process for Surgical Gloves

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 Online (SUGAM) 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 the Notified Body conducts it before the licensing authority grants the licence.
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).

CDSCO Registration Fees and Timeline for Surgical Gloves

The Second Schedule of the Medical Devices Rules sets the fees, and you pay them online through the CDSCO portal. Also, 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). 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. In fact, a test licence (Form MD-13) carries a modest fee. Always confirm the current figure on the CDSCO portal before filing.

Furthermore, a complete Class B manufacturing file typically clears in about three to six months. An import (MD-15) file usually takes six to nine months. Also, 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

Typical query reasons for glove applications are:

AQL / freedom-from-holes results missing or above the acceptable limit.
Latex gloves with no protein-content or sensitisation data.
Surgical gloves filed against the examination-glove standard (or vice versa).
Sterilisation validation absent for sterile gloves.
Free Sale Certificate scope not covering all sizes/materials 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 Surgical Gloves

What CDSCO class are surgical gloves?

Sterile surgical gloves are Class B. Moreover, a domestic manufacturer files Form MD-3 for an MD-5 licence from the State Licensing Authority. An importer files Form MD-14 for an MD-15 licence.

Which standard applies to surgical gloves in India?

IS 4148 is the Indian Standard for rubber surgical gloves; ISO 10282 is the international equivalent, and examination gloves follow IS 15354 / ISO 11193.

Are examination gloves regulated the same way?

Examination gloves are also notified medical devices, but they are usually non-sterile and follow a different standard, so they should be registered as their own product with the correct evidence.

Do latex surgical gloves need special data?

Yes — because of latex-allergy risk, CDSCO expects biocompatibility and protein-content data, and the label must carry a natural-rubber-latex caution.

How long does a surgical-glove CDSCO licence take?

A complete Class B manufacturing (MD-5) file usually clears in about three to six months. In addition, an import (MD-15) file typically takes six to nine months.

Does CDSCO require a factory audit?

Yes — for Class B manufacture, a CDSCO-empanelled Notified Body audits the site before the licensing authority grants the MD-5 licence.

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 surgical gloves against the current CDSCO list before we draft anything.
Route selection — manufacture (MD-3/MD-5) or import (MD-14/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 SUGAM 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 surgical gloves — from classification and route selection to Device and Plant Master File preparation, SUGAM filing, audit support and the licence grant. Also, whatsapp or call +91 9289587478, or email admin@pcnindiaglobal.com, to get your registration underway.

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