India’s Medical Device Regulatory Landscape

by | Jul 1, 2019 | FDA, Medical Devices, Pharmaceuticals, Quality Systems, Regulatory

India’s medical device market is growing exponentially. The medical device industry in India is presently valued at $5.2 Billion and is growing at 15.8% CAGR. Currently, India is considered among the top 20 global medical device markets and is the 4th largest medical device market in Asia after Japan, China, and South Korea.1 You definitely wouldn’t want to miss out on the opportunity to sell your device in this booming market!

Let’s take a quick look at what the regulatory landscape in India looks like:

Medical devices in India are regulated by the ‘Central Drug Standard Control Organisation’ (CDSCO), a body of the Ministry of Health and Human Welfare in India. Medical devices are classified as Class A, Class B, Class C or Class D based on the risk associated with the device, with Class A being devices with the lowest risk. Only those medical devices that are listed in the ‘Medical Devices Rule 2017’ are being regulated; however, new devices are being added to the list from time to time by the Ministry of Health and Human Welfare.2

If you wish to import your device to India, you will have to appoint an authorized representative/agent who holds a valid wholesale license and will be responsible for communicating with the regulatory body on your behalf.

Manufacturers that have received market authorization in the USA, Europe, Australia, Canada, and Japan may be eligible to receive a free sale certificate and will be able to sell their devices in India with minimum conformity assessment. The Central Licensing Authority within the CDSCO might cause an inspection by the notified body of manufacturing sites outside of India.2

Applications can be submitted via the Ministry of Health’s online portal with a fee associated with it. The CDSCO will review the application and issue an import registration certificate. The certificate never expires; however, the registration fees are due every 5 years.2

With a local office in India, EMMA International can help you along the way to obtain approval for your medical device in India. Give us a call at 248-987-4497 or email us at info@emmainternational.com for additional information.


1Nishith Desai Associates (April 2019) The Indian Medical Device Industry retrieved on 06/26/2019 from http://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/The_Indian_Medical_Device_Industry.pdf

2TUV India: REGULATION OF MEDICAL DEVICES IN INDIA retrieved on 06/26/2019 from https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/regulation-of-medical-devices-in-india

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Ready to learn more about working with us?

Pin It on Pinterest

Share This