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September 22, 2026October 12, 2026
CDSCO, Compliance Guides, Import Compliance, Medical Devices

CDSCO Licence for Autoclaves & Sterilizers in India: Class B Registration, ISO 17665 and Process

A steam sterilizer (autoclave) makes reusable instruments safe to use again, so its cycle performance underpins infection control across every hospital and clinic. CDSCO regulates the medical sterilizer as a Class B device with the moist-heat sterilization standards and cycle validation behind the licence. This guide covers the full CDSCO pathway for autoclaves and sterilizers under the Medical Devices Rules, 2017 — classification, licence route, ISO 17665 and EN 285, the documents, the fees and the timeline. (Confirm the exact class for large/industrial sterilizers against the current CDSCO list.)

Is a CDSCO Licence for Autoclaves & Sterilizers Mandatory in India?

Yes. A medical sterilizer is 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; an importer holds a Form MD-15 import licence through an Indian Authorised Agent. Tabletop, front-loading and large steam sterilizers fall within the framework.

Risk Classification of Autoclaves & Sterilizers

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.

Autoclaves & Sterilizers are classified as Class B (low-to-moderate risk). A sterilizer is a device whose failure leaves instruments non-sterile and creates an infection risk, but which does not itself contact the patient, 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.

CDSCO Licence for Autoclaves & Sterilizers: Which Licence You Need

To manufacture autoclaves & sterilizers 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 autoclaves & sterilizers (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 Autoclaves & Sterilizers

Autoclaves are evaluated against the moist-heat sterilization standards plus equipment and pressure safety:

ISO 17665 — sterilization of health-care products: moist heat: requirements for development, validation and routine control.
EN 285 — sterilization: steam sterilizers: large sterilizers (or EN 13060 for small steam sterilizers).
IEC 61010-2-040 — safety requirements for sterilizers using steam.
IEC 60601-1 / IEC 60601-1-2 — where the sterilizer is treated as medical electrical equipment.
Pressure-vessel safety conformity (and, in India, relevant statutory pressure-vessel requirements).
Cycle-validation and Bowie-Dick / biological-indicator evidence.

Documents Required for Autoclaves & Sterilizers 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 autoclaves & sterilizers:

Cycle-validation reports (ISO 17665) — temperature/time/pressure profiles for each cycle.
EN 285 / EN 13060 type-test evidence as applicable to size.
Electrical and steam-safety reports (IEC 61010-2-040).
Pressure-vessel conformity documentation.
Biological/chemical-indicator and Bowie-Dick performance evidence.
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 Autoclaves & Sterilizers

Autoclave labelling and the IFU are checked for cycle, safety and pressure information:

Device name, model and chamber volume, and rated cycle parameters.
Manufacturer name and address, and the CDSCO licence number.
Rated electrical/steam supply and pressure rating with safety symbols.
Batch/serial identification and the date of manufacture.
Cycle selection, loading and validation/routine-monitoring information in the IFU.

Cycle Validation Is the Product

An autoclave is judged less on its hardware than on its cycles: CDSCO expects moist-heat cycle validation to ISO 17665 and type-test evidence (EN 285 for large, EN 13060 for small sterilizers), plus routine-monitoring aids such as Bowie-Dick tests and biological indicators. Because it is a pressure vessel, statutory pressure-vessel safety also applies. Decide the sterilizer size and cycles, and get the validation and pressure-safety evidence right — a sterilizer without validated cycles is an incomplete file.

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 autoclave applications are:

Cycle-validation (ISO 17665) evidence missing or incomplete.
Wrong type-test standard for the sterilizer size (EN 285 vs EN 13060).
Steam/electrical-safety (IEC 61010-2-040) reports absent.
Pressure-vessel conformity not documented.
Free Sale Certificate scope not covering the model 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 an autoclave/sterilizer?

A medical steam sterilizer is Class B. A domestic manufacturer files Form MD-3 for an MD-5 licence; an importer files Form MD-14 for an MD-15 licence. Confirm the class for large/industrial sterilizers on the current CDSCO list.

Which standards apply to sterilizers in India?

ISO 17665 for moist-heat sterilization validation, EN 285 (large) or EN 13060 (small) type tests, and IEC 61010-2-040 for steam-sterilizer safety.

What is the key evidence for a sterilizer?

Cycle validation to ISO 17665 with routine-monitoring aids (Bowie-Dick, biological indicators) — a sterilizer without validated cycles will not clear.

Do pressure-vessel rules apply?

Yes — an autoclave is a pressure vessel, so statutory pressure-vessel safety requirements apply alongside the CDSCO device licence.

How long does 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 autoclaves & sterilizers 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 autoclaves & sterilizers — 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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