This document discusses medical devices and the regulations around them in India. It provides classifications for medical devices from class A involving lowest risks to class C involving moderate to high risks. Some examples are given for each class. It outlines the regulatory structure in India, noting that the CDSCO is the key regulatory organization. It also discusses the growth of the Indian medical devices market, expected to be worth $11 billion by 2023, and some of the drivers and challenges for the sector. Top medical device companies operating in India are also mentioned.

1. Medical devices
Presented by :
Gajanan deshmukh (06)
Tushar bhosale (07)

2. Medical devices
A medical device is an instrument, apparatus, implant, in
vitro reagent, or similar or related article that is used to
diagnose, prevent, or treat disease or other
conditions, and does not achieve its purposes through
chemical action within or on the body

3. Classification of medical devices
i) Class A- devices involving lowest risk levels
ii) Class B- devices involving low to moderate risks
iii) Class C- devices involving moderate to high risks

4.  Class A
• Oxygen Mask
• „ Line Isolation Monitor
• „ Intra-Oral Dental Drill
• „ Powered Toothbrush
 Class B
• Nebulizer
• „ Cardiac Monitor
• „ Hemodialysis System
• „ Electro-Surgical Cutting & Coagulation Device
• „ Surgical Laser for Dermatology Use
 Class C
• Cardiovascular Stent
•„ Intra-Aortic Ballon
•„ Implanted Urinary Continence Device
•„ Implantable Diaphragmatic/Phrenic Nerve Stimulator
•„ Membrane Lung for Long Term Pulmonary Support

5. Medical device regulations in
India
• Registration procedures for certain classes medical devices
regulated under the provisions of the Drugs and Cosmetics
Rules.
• Currently, manufacturers of medical devices which require
registration can leverage their approvals in the US, Canada,
Europe, Australia or Japan to register their medical devices in
India .
• The hierarchy of medical device regulatory entities in India is
as follows:
Ministry of Health and Family Welfare

6. Organogram of medical device division
(CDSCO) (HQ)
Drug controller
general of India
Deputy drug
controller of India
Assistant drug
controller India
Medical devices
cell
Drug Inspectors
Technical data
associates
Diagnostic cell
Drug Inspectors
Technical data
associates

7. India’s Latest Medical Device
Regulation Developments
• India ranks fourth in Asia for largest medical device
markets (following Japan, China, and South Korea).
• Roughly 75% of the medical device market in India
consists of imported products . Despite this high
percentage of imports, India does not comprehensively
regulate many of the medical devices (both local and
foreign).
• CDSCO is the key medical regulatory organization in
India.
• Indian government has identified medical devices
regulation as a key issue that needs to be addressed.

8. • Medical Device Registration Application Guidelines
• Medical Device Clinical Trials Application Guidelines
• Medical Device Manufacturing License Application
Guidelines
• Medical Device Import License Application
Guidelines

9. Top medical device companies in
India
• 3M
• India medtronic
• Becton dickinson
• B. Braun Medical (I) Pvt. Ltd.
• BL Life sciences Limited
• Baxter India
• GE healthcare
• Johnson & Johnson Medical India (JJMI) Ltd.
• Abbott vascular

10. Medical device Market
• The Indian medical devices market is expected to be worth $11
billion by 2023.
• Global medical device market is around 252 billion US doller.
• In 2011, the Indian medical devices market generated $3 billion
in sales.
• The opportunities lie in the emerging regions of the country. With
the market relying largely on imports, the country provides
significant opportunities for multinational medical device
manufacturers.
• The domestic manufacturers are mostly engaged in low-value
products like syringes, needles, catheters, blood collection
tubes, medical electronics, medical equipment and implants.

11. • The Indian medical devices market will benefit from the
expansion of health Insurance.
• Future growth in the medical devices market is also
expected to be driven by patient demographics,
particularly with the rise in the country's aging
population, which has fuelled increased incidence of
age-related diseases, such as cardiovascular disease and
Alzheimer's disease.

12. Drivers for growth of medical
technology sector in India
• Economic growth leading to higher disposal incomes
• Increased public spending in healthcare
• Increased private investment in healthcare
• Increased penetration of health insurance
• Emergence of new models of healthcare delivary
• Public private partnership route to innovation

13. KEY CHALLENGES FACED BY
SECTOR
• Low penetration
• Accessibility
• Affordability
• Awareness
• Nascent regulatory environment
• High capital requirement

14. Medical Devices Cleared or Approved
by FDA in 2013

15. ArterX Surgical Sealant - P100030

16. Resolute Integrity Zotarolimus-Eluting Coronary
Stent System (Resolute Integrity) –
P110013/S005

17. Prometra® Programmable Infusion
Pump System - P080012

18. Ablation Catheter

19. Abbott RealTime HBV Assay - P08002

20. CONCLUSION
• Growth is 23 %
• Huge talent pool.
• Huge opportunity.
• Export opportunity.
• Low cost devices.

21. References
 http://www.emergogroup.com/services/india/india-medical-device-registration
 http://www.biospectrumasia.com/biospectrum/news/122665/india-medical-
devices-market-touch-usd11-bn-2023#.UVtcyBcqZD4
 http://entrance-exam.net/top-medical-device-companies-in-india/
 http://www.ewh.ieee.org/r6/scv/pses/ieee_s_pses_jan08.pdcvf
 http://cdsco.nic.in/Organogram%20of%20Medical%20Device.pdf

22. Thank you