India Medical Device Market

Boasting the world’s second largest population, India is a massive market offering a ton of potential for medical device manufacturers. While the Indian government has launched numerous programs to try and support R&D investments in their country, India still imports 90% of all sophisticated devices they need. Currently, it is the 4th largest medical device market in Asia, with their market size expected to grow by ~28% to reach $50 billion by 2025. Most of this growth can be attributed to citizens’ rising disposable income and significant government investments in healthcare infrastructure throughout the country.

Medical devices are overseen by the Central Drugs Standard Control Organization (CDSCO) which was established under the Drugs and Cosmetics Act of 1940 to regulate the importation, manufacturing and distribution of drugs in the country. While India has approved several amendments to the original Act, India’s regulatory process remains fairly unsophisticated and instead, provides manufacturers with a specific list of device types that require registration. 

List of notified Medical Devices 

• Disposable Hypodermic Syringes
• Disposable Hypodermic Needles
• Disposable Perfusion Sets
• IVD Devices for HIV, HBsAg, HCV
• Cardiac Stents
• Drug Eluting Stents
• Catheters
• Intra Ocular Lenses
• I.V. Cannulae
• Bone Cements
• Heart Valves
• Scalp Vein Set
• Orthopaedic Implants
• Internal Prosthetic Replacements
• Blood Grouping Sera
• Ligatures, Sutures and Staplers
• Intra Uterine Devices (CuT)
• Condoms
• Tubal Rings
• Surgical Dressings
• Umbilical tapes
• Blood/Blood Component Bags
• Ablation Devices
• Organ Preservation Solution
• Blood Pressure Monitors
• Digital Thermometers 
• Glucometers 
• Nebulizers 
• X-Ray Machines (Effective April 1, 2021)
• CT Scan Equipment (Effective April 1, 2021)
• MRI Equipment (Effective April 1, 2021)
• PET Equipment (Effective April 1, 2021)
• Defibrillators (Effective April 1, 2021)
• Dialysis Machines (Effective April 1, 2021)
• Bone Marrow Cell Separators (Effective April 1, 2021)
• All Implantable Medical Devices (Effective April 1, 2021)
• Ultrasound Devices (November 1, 2021)
• Disinfectants and insecticides specified in Medical Device Rules, 2017

*Seek guidance on application of categories

Information updated on June 14, 2021. Learn more about the updated regulations here.

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Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in India.

Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the India medical market.