DISCOVER INDIA
The Emerging Hub for Cardiology
The cardiac devices market is expected to grow from $2.2 billion in 2022 to $4.6 billion by 2028, at a compound annual growth rate (CAGR) of 11%.
The electrophysiology market is projected to expand from $0.7 billion in 2022 to $1.5 billion by 2028, with a 12% CAGR.
The cardiovascular imaging market is forecasted to increase from $1.3 billion in 2022 to $2.3 billion by 2028, at a 9% CAGR.
Key Growth Drivers Fuelling Market
Cardiovascular diseases (CVDs) are the leading cause of death in India. According to the World Health Organization (WHO), about 23% of deaths in India are due to CVDs.
Patients are increasingly demanding minimally invasive procedures, which have a shorter recovery time and lower risk of complications. This is driving the demand for catheter ablation and transcatheter aortic valve replacement.
The disposable income of Indians is rising, which is making them more willing to spend on healthcare. This is expected to boost the demand for expensive cardiology medical devices, such as implantable cardioverter defibrillators (ICDs) and pacemakers.
NAVIGATING THE REGULATORY LANDSCAPE
Step-by-Step Registration Process
Product Registration
Cardiology 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 cardiology 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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