Current Regulation on Medical Devices & In-vitro Diagnostics Devices

Current Regulation
on Medical Devices
& In-vitro
Diagnostics Devices
ASEEM SAHU
Dy. DRUGS CONTROLLER (I)
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
DIRECTORATE GENERAL OF HEALTH SERVICES
MINISTRY OF HEALTH AND FAMILY WELFARE
GOVERNMENT OF INDIA
Proposed Regulations
Amendments
To
the Drugs and Cosmetics Act
Drugs and Cosmetics(Amendment) Bill 2013
 Drugs, Cosmetics and Medical Devices Act
 New Definitions for - Medical Device, In-vitro Diagnostics Devices,
investigational/new medical devices & IVD, Manufacturers, Clinical Trial,
QMS, Medical Device Officer, Notified Body, Performance Evaluation
etc.
 Separate Chapter II A for Medical Devices.
 Clinical trial Requirements
 “Medical Device Officer” in place of “Drugs Inspector”
 Medical Devices Technical Advisory Board & Medical Devices
Consultative Committee.
 Defined misbranded, adulterated and spurious medical devices.
 Standards for Medical Devices
 Role of Notified Bodies
 Penal Provisions
Strengthening of MD Regulatory regime under 12th Five Year Plan
S.N
Proposal
1
Manpower
2
Experts (Bio-Medical Tech, Bio materialist, Plastic eng,
Electronic eng etc
3
Medical Devices Testing Laboratories (Five)
(50 Personnel each lab)
4
Diagnostic Devices Testing Laboratories (Three)
(50 Personnel each lab)
5
National Drug Regulatory Training Academy
(50 Personnel)
6
Funds for International Travel
7
IT Enabled Services
8
Overseas Country Offices
Conclusion
 Regulated as Drugs
 Not all devices are regulated
 Different from Drugs
 No separate regulations
 Proposed amendments to Act
 Strengthening of Regulation under 12th Five
Year Plan (Rs 1800 Cr)
Thank you