The Indian medical device industry is fast becoming a cornerstone of the nation’s healthcare system and a driver of economic growth. Fueled by the growing demand for affordable healthcare, proactive government reforms, and increasing global interest, India’s medical device sector is on a rapid growth trajectory, currently ranking as the fourth-largest market in Asia, with a valuation of $14 billion and exports totaling $3.7 billion. Yet for many, be it manufacturers, importers, or distributors, the journey forward remains challenging, particularly when navigating the evolving regulatory landscape and intricate policy frameworks.
In this context, “India’s Medical Device Industry: Growth Opportunity and Regulatory Pathways” by Seema Dutt emerges as an essential guide. Offering a comprehensive look at both market dynamics and compliance frameworks, the book is a valuable resource for anyone looking to understand, operate, or invest in the rapidly expanding Indian medical device industry.
Let’s explore what is inside the book.
Inside the Book: What You’ll Discover
The book explores the Indian medical device industry through both a strategic and regulatory lens. It covers:
- An overview of the medical device market in India: Providing a comprehensive overview of the Indian medical device market, highlighting its current size, growth projections, import dependence, and key drivers such as government policies, a skilled workforce, increasing healthcare demand, and demographic trends.
- Pre-Requisites for Medical Devices Registration in India: Which includes specific regulatory requirements established by the Central Drugs Standard Control Organization (CDSCO) that foreign companies must fulfill to import and sell medical devices in India.
- Registration Types and Pathways: This section provides a detailed overview of medical device’s risk classification and applicable regulatory approval pathways such as those for importing devices with or without predicate etc.
- Documentation for various regulatory pathways: Included in this section is a comprehensive overview of the documentation and regulatory requirements corresponding to the pathways discussed in the previous section. It outlines in detail the specific forms, certificates, and documents required for a successful application submission.
- Approvals from Other Regulatory Bodies: In addition to the regulatory approvals from the Central licensing authority, there are additional approvals that may be applicable to the medical device being imported. This section provides a brief about the possible applicable approvals from authorities such as the Legal Metrology Department, Wireless Planning and Coordination (WPC) Wing, Bureau of Indian Standards (BIS), Atomic Energy Regulatory Board (AERB), Central Pollution Control Board (CPCB), and National Pharmaceutical Pricing Authority (NPPA).
What does the book offer?
- A clear understanding of the potential of India’s medical device market
- In-depth insights into the regulatory landscape
- Strategic guidance for market entry highlighting possible regulatory pathways
- Comprehensive listing of document requirements
- Actionable knowledge to support compliance
Who Should Read This Book
- Medical device manufacturers and distributors seeking to enter or expand in India
- Regulatory affairs professionals and consultants looking for a reliable reference
- Entrepreneurs and startups in the health technology sector
- Legal and compliance professionals managing global medical device portfolios
- Business students and researchers interested in emerging healthcare market
Where to Find the Book
India’s Medical Device Industry: Growth Opportunities and Regulatory Pathways is now available on Amazon.
About the Author
Seema Dutt, a seasoned regulatory consultant with 25+ years working with the medical device and pharmaceutical industry in the areas of regulatory affairs, quality assurance, clinical trial coordination, pharmacovigilance and technical documentation, brings deep expertise in navigating the regulatory pathway for medical device’s industry. In 2011 she started her own consultancy firm “Regulatory Solutions India” and since then has helped clients from more than 20 countries to register almost 500 medical devices across 16+ categories.
Don’t miss this opportunity to equip yourself with the insights needed to thrive in one of the world’s fastest-growing medical device markets.
About Regulatory Solutions India (RSI)
Regulatory Solutions India specialize in registration services for the medical devices, IVDs, and cosmetics in India. If you’re looking to expand into the Indian market, we’d be glad to support your regulatory journey and contribute to your success.
Contact us with your specific requirements and we will take it forward from there.
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