Medical devicesPresented by :Gajanan deshmukh (06)Tushar bhosale (07)
Medical devicesA medical device is an instrument, apparatus, implant, invitro reagent, or similar or related article that is used todiagnose, prevent, or treat disease or otherconditions, and does not achieve its purposes throughchemical action within or on the body
Classification of medical devicesi) Class A- devices involving lowest risk levelsii) Class B- devices involving low to moderate risksiii) 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 inIndia• Registration procedures for certain classes medical devicesregulated under the provisions of the Drugs and CosmeticsRules.• Currently, manufacturers of medical devices which requireregistration can leverage their approvals in the US, Canada,Europe, Australia or Japan to register their medical devices inIndia .• The hierarchy of medical device regulatory entities in India isas follows:Ministry of Health and Family Welfare
Organogram of medical device division(CDSCO) (HQ)Drug controllergeneral of IndiaDeputy drugcontroller of IndiaAssistant drugcontroller IndiaMedical devicescellDrug InspectorsTechnical dataassociatesDiagnostic cellDrug InspectorsTechnical dataassociates
India’s Latest Medical DeviceRegulation Developments• India ranks fourth in Asia for largest medical devicemarkets (following Japan, China, and South Korea).• Roughly 75% of the medical device market in Indiaconsists of imported products . Despite this highpercentage of imports, India does not comprehensivelyregulate many of the medical devices (both local andforeign).• CDSCO is the key medical regulatory organization inIndia.• Indian government has identified medical devicesregulation as a key issue that needs to be addressed.
• Medical Device Registration Application Guidelines• Medical Device Clinical Trials Application Guidelines• Medical Device Manufacturing License ApplicationGuidelines• Medical Device Import License ApplicationGuidelines
Top medical device companies inIndia• 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 $11billion by 2023.• Global medical device market is around 252 billion US doller.• In 2011, the Indian medical devices market generated $3 billionin sales.• The opportunities lie in the emerging regions of the country. Withthe market relying largely on imports, the country providessignificant opportunities for multinational medical devicemanufacturers.• The domestic manufacturers are mostly engaged in low-valueproducts like syringes, needles, catheters, blood collectiontubes, medical electronics, medical equipment and implants.
• The Indian medical devices market will benefit from theexpansion of health Insurance.• Future growth in the medical devices market is alsoexpected to be driven by patient demographics,particularly with the rise in the countrys agingpopulation, which has fuelled increased incidence ofage-related diseases, such as cardiovascular disease andAlzheimers disease.
Drivers for growth of medicaltechnology 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 BYSECTOR• Low penetration• Accessibility• Affordability• Awareness• Nascent regulatory environment• High capital requirement
Medical Devices Cleared or Approvedby FDA in 2013