2. INTRODUCTION
A medical device can be any instrument,
apparatus, implement, machine, appliance,
implant, reagent for in vitro use, software,
material or other similar or related article,
intended by the manufacturer to be used,
alone or in combination for a medical purpose
3.
4. REGULATION IN INDIA
In India medical devices are governed by
CDSCO(Central Drugs Standard Control Organization)
which is regulated by Directorate General of Health
Services , Ministry of Health and Family Welfare ,
Government of India.
CDSCO is the only government body which regulate the
medical devices.
5. Many committees had been set up and given their
opinion and recommendation , like the Mashelkar
Committee – Central Drug Standard Control
Organization.
All these are now being taken into to form by the
Indian Medical Device regulatoryAct (IMRDA).
Indian Medical Devices RegulatoryAct came in
force on December 31,2009.
6. The composition of the committee is
represented by:
Central Governing Authority
Eminent Jurist
Two eminent medical practitioners
Two eminent medical technologists
Secretary General Quality council
7. IMRDA ESSENTIAL PRINCIPLES
Should not compromise health and safety
Design and manufacture of devices must conform
with safety principles
Long term safety should be ensured
Benefits of the devices must outweigh any side effects
Medical devices should be useful for the intended
purpose
8. IMRDA OBJECTIVES
Provide notification of essential principles
Provide for risk based classification of devices
Notify standards and guidelines
Provide mechanism of conformity
Provide a post market surveillance system
Provide for enforcement
9. IMRDA The regulation
Will issue
Design and manufacturing requirements
Performance evaluation
Demonstration of device standards , testing and
compliance
Regulation of post marketing follow up
Regulation of recalls
Legislate and punishment for non compliance
Principle of safety
10. IMRDA classification
ClassA– Devices involving low risk levels
Class B– devices involving low to medium risk
Class C – Devices involving moderate to high risk
Class D– Devices involving high risk.
11.
12.
13. The Drug and Cosmetic Act
Covers the pharmaceutical products and cosmetic.
Added medical devices as early as1992(syringes ,
needles, etc.)
As per the latest list of regulated medical devices , issued
on the 20/04/2010 , listed following devices:
Disposable hypodermic needles
Disposable hypodermic syringes
Disposable perfusion sets
In vitro diagnostic devices for HIV, HbsAg.
Cardiac stents
15. The Drug and Cosmetic Act
Additionally following products are regulated as ‘Drugs’
under Drugs & CosmeticsAct & Rules there under:-
Blood grouping sera
Ligatures , sutures & staplers
Intra uterine devices
Condoms
Tubal rings
Surgical dressings
Blood/blood related products
16. SIGNIFICANCE OF MEDICAL DEVICES
The medical development in terms of drugs and
devices has brought about the robust change in the life
of the people.
Medical devices have extended the ability of
physicians to diagnose and treat diseases, making great
contributions to health and quality of life.
Like medicines and other health technologies, they are
essential for patient care at the bedside, at the rural
health clinics or at the large specialized hospitals.
17. ROLE OF PHARMACIST IN REGULATION
ON USE OF MEDICAL DEVICES
Pharmacist should:
Have proper understanding of medical device
safety, risk involved, the degree of invasiveness,
duration of contact, the body system affected, and
local versus systemic effects.
Be actively involved in the regulation of
effectiveness and performance of medical device.
18. LATEST DEVELOPMENT IN
MEDICAL DEVICE REGULATION
There are only14 medical devices regulated by Drug
Controller General of India (DCGI).
Currently, a number of specific medical devices are
regulated as drugs and fall under India’s Drugs and
CosmeticsAct (DCA).
Since 2008, both the Indian Department of Science and
Technology and the Ministry of Health have sought to
completely restructure the regulations for medical devices.
19. Department of Science and Technology : proposed creation
of a Medical Devices Regulatory Authority that would
operate similar to a division within the CDSCO.
Ministry of Health: proposed revision of the DCA that
would create a Central Drug Authority to function similarly
to the U.S. FDA.
The CDSCO is continuing to entrench its own medical
device regulation standards. In June 2009, it seemed as if
the CDSCO would begin its own form of medical device
regulations.
20. CDSCO: released schedule M-3 which provided an official
definition for medical devices, outlined a four level
medical device risk classification scheme, created a body
within the CDSCO to regulate medical devices in India.
Ministry of Health and Family Welfare, Government of
India, with WHO funding, initiated a country wide
National Pharmacovigilance Program.
