pcnindiaglobal
October 8, 2026October 12, 2026
CDSCO, Compliance Guides, Import Compliance, Medical Devices

CDSCO Licence for Hearing Aids in India: Class B Registration, IEC 60118 and Process

A hearing aid amplifies and shapes sound for people with hearing loss, and its performance and safe output level directly affect the user. CDSCO regulates the hearing aid as a Class B device with the hearing-aid performance standards behind the licence. This guide covers the full CDSCO registration pathway for hearing aids under the Medical Devices Rules, 2017 — classification, licence route, the IEC 60118 series, the documents, the fees and the timeline. This guide explains CDSCO registration for hearing aids in India — risk class, licence forms, standards, documents, fees and timeline.

Is a CDSCO Registration Mandatory for Hearing Aids?

Yes. A hearing aid 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. Behind-the-ear, in-the-ear and receiver-in-canal hearing aids fall within the framework.

Risk Classification of Hearing Aids

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.

Hearing Aids are classified as Class B (low-to-moderate risk). A hearing aid is a device that compensates for a disability and whose sound output affects the user, 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 Hearing Aids

To manufacture hearing aids 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 hearing aids (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 Hearing Aids

Hearing aids are evaluated against the hearing-aid performance standards plus electrical safety:

IEC 60118 series — electroacoustics: hearing aids (performance measurement and characteristics).
IEC 60118-0 — measurement of electroacoustical characteristics. And IEC 60118-7 for production-test characteristics.
IEC 60601-1 — where applicable to the electronics/charging.
IEC 60601-1-2 — electromagnetic compatibility (EMC).
Maximum-output / OSPL90 limits to protect against over-amplification.
ISO 10993 series — biocompatibility of ear-contacting components.

Documents Required for CDSCO Registration of Hearing Aids

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 Hearing Aids

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

IEC 60118 performance reports — gain, frequency response, distortion and maximum output (OSPL90).
Electrical-safety / EMC and battery-charging evidence where relevant.
Biocompatibility for ear-canal-contacting parts.
Software / fitting-algorithm documentation where the device is programmable.
Output-limiting evidence to prevent hearing damage.
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 Hearing Aids

Hearing-aid labelling and the IFU are checked for output and use information:

Device name, model and style (BTE/ITE/RIC), and the maximum output level.
Manufacturer name and address, and the CDSCO licence number.
Batch/serial identification and the date of manufacture.
Battery type and, where programmable, the fitting/compatibility information.
Cleaning, fitting and output-safety information in the IFU.

Medical Hearing Aid vs Consumer Amplifier

The line to get right is between a hearing aid — a medical device intended to compensate for hearing loss — and a personal sound amplifier marketed as a consumer gadget. If the product is intended to help hearing-impaired users, it is a Class B medical device and needs a CDSCO licence, whatever the marketing says. Programmable and app-controlled models add a fitting-software element that is assessed. Fix the intended use and the maximum-output limiting before drawing test reports.

Step-by-Step CDSCO Registration Process for Hearing Aids

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 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 Hearing Aids

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 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. 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 typically clears 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 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

Common query reasons for hearing-aid applications are:

IEC 60118 performance data missing or not for the exact model.
No maximum-output (OSPL90) limiting evidence.
Programmable models with thin fitting-software documentation.
Biocompatibility absent for ear-contacting parts.
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.

FAQs on CDSCO Registration for Hearing Aids

What CDSCO class is a hearing aid?

A hearing aid is 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.

Which standard applies to hearing aids in India?

The IEC 60118 series for hearing-aid electroacoustic performance, with electrical-safety/EMC evidence for the electronics where relevant.

Is a consumer sound amplifier a medical device?

If it is intended to help people with hearing loss, yes — it is a Class B medical device and needs a CDSCO licence regardless of consumer-style marketing.

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.

How long does hearing-aid registration take?

A complete Class B manufacturing (MD-5) file usually clears 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.

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 hearing aids 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 hearing aids — 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.