Are you looking into seizing an opportunity in India’s medical device market? Andaman Medical India is commencing its operation in 2020. We are excited to assist you in regulatory matters and contribute to your business development in India. We will be sharing more on our new division soon.
India is the fourth largest medical device market in Asia after Japan, China and South Korea. The current medical device market size is estimated to be worth USD 5.2 billion, with projections that India will become the world’s most populous nation by 2024, with a medical device market size between USD 9.3bn to 10.8bn. This provides an opportunity to help to shape the Indian medical device market and to enhance the quality of life of those living in India.
Andaman Medical may be able to help you to seize this opportunity. From 2020, Andaman Medical will expand its footprint in India. We aim to assist you in navigating the complex regulatory requirements by being the local license holder, facilitating registration processes with authorities, providing regulatory intelligence work and business development services.
For medical device regulations in India, the regulatory body responsible for medical device registration is the Central Drug Standards Control Organization (CDSCO). Only notified medical devices shall undergo registration with CDSCO. Currently, there are about 30 medical device product families that require registration. For example, disposable hypodermic needles, catheters, drug eluting stents and bone cements require registration with CDSCO. By the 1st of April 2020, blood pressure monitoring devices, CT scanning equipment, MRI equipment, defibrillators and dialysis machines are some of the devices that are scheduled for regulation.
We look forward to sharing more information on Indian regulatory updates and news of Andaman Medical India.
Andaman Team India