The Emerging Hub for ENT

Indian ENT Devices Growth

Indian ENT Devices

The Indian ENT devices market is projected to grow from $420 million in 2022 to $820 million by 2030, registering a CAGR of 9% during the forecast period of 2022-2030.

Hearing Loss Market Expansion

Hearing Loss
Market Expansion

The hearing loss market in India was valued at $220 million in 2022 and is projected to reach $350 million by 2030, registering a CAGR of 8% during the forecast period.

Tonsillitis Market Forecast

Tonsillitis Market

The tonsillitis market in India was valued at $150 million in 2022 and is projected to reach $200 million by 2030, registering a CAGR of 5% during the forecast period.

Key Growth Drivers Fuelling Market ​

Rising prevalence of ENT disorders

About 63 million people in India suffer from hearing loss. The rising prevalence of these disorders is a major driver of the ENT medical devices market. 

Growing geriatric population

People aged 60 and above in India is expected to increase from 103 million in 2020 to 236 million by 2050, which is expected to drive the demand for ENT medical devices.

Growing focus on preventive healthcare

The Indian government is increasingly focusing on preventive healthcare. This is leading to increased awareness about ENT disorders and the importance of early diagnosis and treatment. This is expected to drive the demand for ENT medical devices in India.

Key Growth Drivers Fuelling Market ​-ENT-INDIA
Taevas element brand

Navigating the Regulatory Landscape

Step1: Product Registration

ENT medical devices in India are regulated under the Drugs and Cosmetics Act, 1940; and would require to be duly registered in India

Step 2: Appoint an Authorized Indian Agent

Foreign ENT medical device companies must appoint an Indian Authorized Agent with a wholesale license to act on their behalf.

Step 3: Submit the Regulatory Dossier

A dossier under form 40 with required documents must be submitted. This includes:

  • Form 40 and TR6 Challan
  • Power of Attorney
  • ISO 13485 Certificate
  • Full Quality Assurance Certificate
  • CE Design Certificate
  • Free Sale Certificate
  • Other Regulatory Approvals
  • Plant Master File (PMF) and Device Master File (DMF)

Step 4: Obtain Registration Certificate in Form 41

After document submission, the CDSCO will grant license or issue a query letter (if needed). The registration certificate is valid for 3 years

Step 5: Obtain Import License in Form 10

The IAR should directly apply for import license using Form 10 in the CDSCO portal. This process would take 4 to 12 weeks.

Step 6: Marketing in India

Once the process is completed the products can successfully market and sell in India. The IAR must ensure compliance with reporting changes, adverse events, recalls, to the CDSCO, if any.

Market Access Solutions

Launchpad to the Indian Medical Device Market




Market Research

Product Registration

Legal Representation



Imports & Shipments

Warehousing & Inventory Management



Distributor Mapping & Management

Channel Strategy Development



Marketplace Management

Localized Content Creation



Data-Driven Marketing Campaigns

Performance Monitoring & Optimization

Taevas advantage

The Taevas

Taevas stands ready to serve as your custom-fit partner in India, catering to your unique business requirements.

  • As your Indian Authorized Representative (IAR), we ensure your regulatory complianc

  • We identify potential distributors for your products and facilitate initial connection

  • Clients can lead the further development of these distributor relationships

  • Along with being your IAR, we also act as your centralized distributor in India
  • We identify and appoint local distributors in different regions of India, creating a wide and efficient distribution network
  • You can focus on your core business, while we handle the complexities of distribution
  • Along with being your IAR, we also initiate the building of your local presence in India
  • We put together a dedicated team who takes charge of sales partnerships and manages the nuances of business operations
  • We ‘Build’ the infrastructure and set up processes; we ‘Operate’ the business, and when you feel ready, we ‘Transfer’ the control to you

Frequently Asked Questions

We have extensive experience helping ENT device companies expand their global footprint. We understand the unique considerations of the industry and have achieved successful results for our clients

Yes, we can provide several case studies where we’ve worked with similar companies in your industry. For example, we assisted a leading audiology device manufacturer expand into Europe and Asia, resulting in a 150% increase in sales over two years

Our team of experts stays updated on the medical device regulations in various countries. We ensure that your devices meet all compliance requirements and help with the necessary documentation.

Yes, we can assist with achieving the necessary certifications in your target countries. We work with experienced consultants who specialize in CE, FDA, and other certifications.

Our marketing approach for healthcare professionals involves educational content, product demonstrations, and thought leadership. We position your brand as a trusted and innovative player in the ENT device industry.

We can guide you through the procurement process in different countries. Our relationships with healthcare institutions globally can aid in the smooth introduction of your devices into these markets.

Our Client Reviews

“Taevas’ Sales Playbook was a game-changer for our team! It streamlined our approach and armed us with winning strategies. Our sales soared, all thanks to their insightful guidance.”

Michael L Sales Manager

Legal Representation:
“Taevas served as our reliable legal representative, navigating complex regulations effortlessly. Their expertise ensured our compliance, allowing us to focus on business growth.”

Emily L Compliance Officer

Warehouse & Inventory Management:
“Taevas transformed our inventory handling! Their streamlined solutions optimized our operations, minimizing costs and maximizing efficiency.”

Mark C Operations Manager

Operations Manager:
“Taevas’ Market Intelligence team delivered invaluable insights. Their comprehensive analysis helped us identify untapped opportunities, shaping our strategic decisions.”

David M Strategy Lead

“The amalgamation of Taevas’ sales collateral, digital presence solutions, and performance analysis has revolutionized our approach. Their holistic strategies resulted in a significant boost in conversions and brand visibility.”

Lisa H Marketing Manager