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.
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:
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.
Foreign medical device players who wish to enter the Indian market must follow the steps that are mentioned below:
For detailed information on the registration of medical devices, read our blog “The Complete Guide to CDSCO Medical Device Registration”.
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”.
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.