DISCOVER INDIA
The Emerging Hub for Dental Health Investments
Valued at $653 million in 2022, India’s dental care market is estimated to expand at a CAGR of 9.40% till 2030 reaching a staggering $1339 mn
India is called as the “oral cancer capital” of the world with 75,000 to 80,000 new cases every year attributed to its high intake of both smoked and smokeless tobacco products, strongly associated with oral neoplasm
Holding a commanding share of 20.12% Dental implants is the fastest-growing segment followed by Periodontics and laser dentistry with cosmetic dentistry defining the new age of dental aesthetics in India
Key Growth Drivers Fuelling Market
Oral health has become a focal point of wellness in India. A rising consciousness about dental hygiene and preventive care is encouraging more people to seek dental services and products.
With the growth in disposable income, individuals are more inclined to invest in dental healthcare. This financial flexibility has fueled the demand for various dental services and products.
India’s burgeoning aging population needs specialized dental care. This demographic shift is opening new avenues for dental products and services aimed at catering to the unique needs of older adults.
India’s reputation as a hub for affordable, high-quality dental care has attracted a global clientele. Dental tourism is flourishing, further energizing the industry with an influx of international patients.
NAVIGATING THE REGULATORY LANDSCAPE
Step-by-Step Registration Process
Product Registration
Dental medical devices in India are regulated under the Drugs and Cosmetics Act, 1940; and would require to be duly registered in India
Appoint an Authorized Indian Agent
Foreign dental medical device companies must appoint an Indian Authorized Agent with a wholesale license to act on their behalf.
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)
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
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.
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.
Empowering your Success in the Indian Market
Taevas is at the forefront of this expansion, supporting businesses as they navigate and conquer new markets. Our comprehensive range of services for the life sciences include
Market access solutions
Unleash your business potential with seamless market entry and expansion solutions to captivate Indian market, and maximize business impact.
Propel your brand to new heights with dynamic strategies and captivating digital journeys, outpacing your competition in India.
Ignite your brand’s growth and multiply revenue with cohesive expert sales and distribution strategies strategies across Indian market.
DECODING THE PATHWAYS
Launchpad to the Indian Medical Device Market
Partnering with a Distributor
Collaborate with an Indian Authorized Representative
Establish Your Own Entity
Embarking on Success with Taevas
Taevas stands ready to serve as your custom-fit partner in India, catering to your unique business requirements.
As Your Market Entry Partner
- As your Indian Authorized Representative (IAR), we ensure your regulatory compliance
- We identify potential distributors for your products and facilitate initial connections
- You will lead the further development of these distributor relationships
As Your Commercial Partner
- 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
As Your Operational Partner
- 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
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