Discover India’s Potential in Medical Devices
THE DEMAND CATALYSTS
Key Growth Drivers Fuelling Market
A noticeable tilt towards preventive healthcare and the rise of lifestyle diseases boosts the demand for an array of medical devices, thus invigorating market expansion.
With NCDs constituting 50% of the disease burden and accounting for 60% of all deaths in India, the medical device market – critical for long-term disease management – is set to experience substantial growth.
As the world’s most populous nation, with ~73mn middle class households, India’s demand for medical devices is higher than ever, paving the way for unparalleled market potential.
Forecasted to soar to $13 billion by 2026, the burgeoning medical tourism sector is anticipated to catalyze the demand for high-end technological devices, medical equipment, and appliances.
NAVIGATING THE REGULATORY LANDSCAPE
A step-by-step guide to
Medical Device Registration
Product Registration
Medical devices come under the regulation of the Drugs and Cosmetics Act, 1940. All products need to be duly registered in India.
Appoint an Authorized Indian Agent
Foreign manufacturers must have an Indian Authorized Representative holding a 20B and 21B wholesale drug license.
Submit Regulatory Dossier (Form 14)
A dossier with required documents must be submitted under form 14. This step typically takes 6 to 9 months.
Step 4: Obtain Registration Certificate (Form 15)
Upon successful document submission, the CDSCO will grant a license. The registration certificate is valid for 3 years.
Acquire Import License (Form 10)
The distributor directly applies for the Form-10 at the CDSCO. The process lasts between 4 to 12 weeks.
Marketing in India
Upon completion of these steps, your product can successfully enter the Indian market for marketing and sales. Any product changes or recalls in other countries must be reported to the CDSCO promptly by the Indian Authorized Representative (IAR).
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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