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Medical device market (India)

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Tushar Bhosale
Tushar Bhosale

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.

Saúde e medicinaTecnologiaNegócios
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Medical devices Presented by : Gajanan deshmukh (06) Tushar bhosale (07)
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
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
 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
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
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
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.
• Medical Device Registration Application Guidelines • Medical Device Clinical Trials Application Guidelines • Medical Device Manufacturing License Application Guidelines • Medical Device Import License Application Guidelines
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
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.
• 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.
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
KEY CHALLENGES FACED BY SECTOR • Low penetration • Accessibility • Affordability • Awareness • Nascent regulatory environment • High capital requirement
Medical Devices Cleared or Approved by FDA in 2013
ArterX Surgical Sealant - P100030
Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) – P110013/S005
Prometra® Programmable Infusion Pump System - P080012
Ablation Catheter
Abbott RealTime HBV Assay - P08002
CONCLUSION • Growth is 23 % • Huge talent pool. • Huge opportunity. • Export opportunity. • Low cost devices.
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
Thank you

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Medical device market (India)

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