DISCOVER INDIA
The Emerging Hub for Software as a Medical Device
The telemedicine software market in India was valued at $100 million in 2022 and is projected to reach $250 million by 2030, registering a CAGR of 15% during the forecast period.
The remote patient monitoring software market in India was valued at $50 million in 2022 and is projected to reach $150 million by 2030, registering a CAGR of 18% during the forecast period.
The personalized health management software market in India was valued at $30 million in 2022 and is projected to reach $70 million by 2030, registering a CAGR of 12% during the forecast period.
Key Growth Drivers Fuelling Market
The Indian government is taking several initiatives to promote the development and adoption of SaMDs. These initiatives include the National Digital Health Mission (NDHM), which aims to create a nationwide digital health infrastructure.
There have been significant technological advancements in the field of SaMDs in recent years. These advancements have led to the development of more sophisticated and effective SaMDs, which are driving the demand for SaMDs in India.
The Indian healthcare sector is undergoing a digital transformation, with increasing adoption of digital technologies such as telemedicine, telehealth, and remote patient monitoring. This is driving the demand for SaMDs, which can be used to deliver healthcare services remotely and efficiently.
NAVIGATING THE REGULATORY LANDSCAPE
Step-by-Step Registration Process
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
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.
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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