Over the last decade, the medical device industry in India has experienced remarkable growth, driven by increasing demand for a diverse range of medical devices, including consumables, dental products, diagnostic imaging equipment, orthopedics and prosthetics, patient aids, and more. To encourage and regulate this burgeoning sector, the government has introduced a range of reforms and policies. These initiatives aim to foster innovation, ensure quality and safety, and address the diverse needs of the healthcare system.
Despite this progress, a significant gap still exists between India’s current demand and the supply of medical devices. To address this, the government has made essential changes to the FDI policy to promote the import of medical devices into India.
In this blog, we will explore the medical device industry in India and discuss how foreign medical device companies can enter the Indian market.
Market Size of Medical Devices in India
India is the 4th largest medical devices market in Asia, following Japan, China, and South Korea, and is among the top 20 medical device markets worldwide. Let’s delve into the numbers related to the market size of India’s medical devices sector:
- In 2022, the medical device market in India was valued at Rs. 90,000 crore (approximately US$ 11 billion). It is projected to expand to US$ 50 billion by 2030, reflecting a compound annual growth rate (CAGR) of 16.4%.
- The diagnostic equipment market is anticipated to reach US$ 6 billion by 2027, and likely to expand at a CAGR of 16.4% between 2020 and 2030.
- India’s dependency on imported medical devices has increased between November 2022 and October 2023, with a 21% rise in imports, totaling Rs. 61,262.84 crore (US$ 7.23 billion).
Key Market Drivers
There are several factors contributing to the booming medical devices sector in India. The key ones are:
Growing Population: With a population of over 1.4 billion, the demand for medical devices to cater to chronic diseases, diagnostic needs, and advanced treatment options is also increasing.
Aging Demographic: According to the National Statistical Office (NSO) report, India’s aging population was 138 million in 2021, expected to rise to 194 million by 2030. With a growing number of elderly citizens, there is a rising demand for devices related to diagnostics, mobility aids, and chronic disease management.
Increasing Chronic Diseases Due to Lifestyle Changes: According to a report by the International Diabetes Federation, the prevalence of diabetes in India is projected to reach around 74 million by 2025. Not only diabetes but other chronic diseases like cardiovascular conditions, and cancer are also becoming more common due to lifestyle changes, requiring more diagnostic and therapeutic devices.
- Increasing Health Insurance Coverage: India’s national health insurance program “Ayushman Bharat” aims to provide healthcare coverage to 500 million individuals. This has led to a substantial increase in the number of patients seeking medical care, thereby boosting the demand for medical devices.
- Growing Middle-Class and Health Awareness: It is estimated that 8 percent of Indians will earn more than USD 12,000 per annum by 2026 and around 73 million households will turn into middle-class category in the next ten years. The rising income and awareness of medical devices are leading to higher spending on healthcare including the use of wearable health tech and home diagnostic devices.
- Rise of Private Healthcare: The private
healthcare sector in India has been expanding rapidly. As of 2019, 393 hospitals received accreditation from the National Accreditation Board for Hospitals & Healthcare Providers (NABH). This growth has driven the need for high-quality medical devices to meet accreditation standards.
- Medical Tourism: Approximately 2 million patients visit India annually from 78 countries for medical, wellness, and IVF treatments, generating $6 billion for the industry which is expected to reach $13 billion by 2026. This is backed by the Indian government’s “Heal in India” initiative making India a hub for medical tourism and driving the demand for medical devices.
- Favorable Regulatory Environment: Several positive changes to the Indian regulatory framework, pivotal being the Medical Devices Rules, 2017, have made it easier for local manufacturers and importers to enter the Indian market.These factors collectively contribute to the robust growth of the medical devices sector in India.
How Can Foreign Medical Devices Players Access the Indian Market
Foreign medical device players who wish to enter the Indian market must follow the steps that are mentioned below:
- Conduct Market Research: Research on factors such as market demand, competition, pricing, and regulatory requirements to identify the potential export opportunities in India.
- Regulatory Compliance: Foreign medical device companies must understand India’s regulatory framework. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority for medical devices in India and all medical devices must be registered with CDSCO before entering the market
For detailed information on the registration of medical devices, read our blog “The Complete Guide to CDSCO Medical Device Registration”.
- Government Initiatives: Leverage the benefits of government initiatives, such as the reduction of customs duties on essential medical devices, which ease the import of high-quality medical devices into the Indian market. Other initiatives include regulatory harmonization by CDSCO, AIFTA, CEPA, and more.
- Quality Assurance: Ensure that the medical devices conform to the standards set by the Bureau of Indian Standards (BIS), the International Organization for Standardization (ISO), or the International Electrotechnical Commission (IEC). This will enhance credibility and trust among Indian consumers.
To learn more about the BIS standards for medical devices, read our blog “Ensuring Quality in Healthcare: The Role of BIS Standards for Medical Devices”.
- Regulatory Support: You can partner with regulatory consultants specializing in the Indian medical device sector to understand the regulatory pathway specific to your product portfolio and the associated requirements They can help you in a successful registration of your medical device in India.
Future Perspective
With the Indian government’s ongoing support and advancements in technology, the medical devices market in India is set for significant expansion. The government’s initiatives to streamline regulatory processes, support innovation, and develop a robust manufacturing ecosystem are paving the way for easier market access for exporters. These efforts are crucial in facilitating a smoother entry for international medical device companies and enhancing their ability to tap into India’s growing healthcare sector.
We, at Regulatory Solutions India (RSI), specialize in regulatory consulting services for medical devices, IVD’s and cosmetics. We are eager to partner with you and script your success story in India. Drop us a message here for your specific requirements and we will take it forward from there.
