The Emerging Hub for ENT
Indian ENT Devices Growth
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
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
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.Â
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.
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
01
Launch
Market Research
Product Registration
Legal Representation
02
Establish
Imports & Shipments
Warehousing & Inventory Management
03
Connect
Distributor Mapping & Management
Channel Strategy Development
04
Activate
Marketplace Management
Localized Content Creation
05
Scale
Data-Driven Marketing Campaigns
Performance Monitoring & Optimization
The Taevas Advantage
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
What is your experience with global expansion for ENT device companies specifically?
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
Can you provide examples or case studies of your work with similar companies in our industry?
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
How do you handle different medical device regulations and compliance requirements in various countries, especially for ENT devices?
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.
Can you help us ensure our devices meet the certification standards (like CE, FDA, etc.) of our target countries?
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.
Considering the specialized nature of our products, how do you approach targeting and marketing to healthcare professionals?
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.
How would you assist in navigating the procurement process of hospitals and clinics in different countries?
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.
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