2. INTRODUCTION
A medical device is an instrument, apparatus, in vitro
reagent , implant or other similar or related article , which
is intended for use in the diagnosis of disease or other
condition ,or in the cure , mitigation , treatment , or
prevention of disease or intended to affect the structure or
any function of the body and which does not achieve any of
its primary intended purposes through its chemical action
within or on the body.
3. 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.
4. Cont….
Many committees had been set up and given their opinion
and recommendation , like the Mahelkar Committee –
Central Drug Standard Control Organization.
All these are now being taken into to form the Indian
Medical Device regulatory Act (IMRDA).
5. IMRDA
Indian Medical Devices Regulatory Act come in force
December 31, 2009
Inputs to be sent to Dr. B Hari Gopal , Adviser Department
of Science and Technology, New Delhi .
6. IMRDA
The composition of the committee is represented by:
Central Government
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
Class A– 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. 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
12. Catheters
Intra ocular lenses
Drug eluting stents
i.v.cannulae
Bone cement
Heart valve
Scalp vein sets
Orthopedic implant
Internal prosthetic replacement
13. The Drug and Cosmetic Act
Additionally following products are regulated as ‘Drugs’
under Drugs & Cosmetics Act & Rules there under:-
Blood grouping sera
Ligatures , sutures & staplers
Intra uterine devices
Condoms
Tubal rings
Surgical dressings
Umbilical cord
Blood/blood related products
14. 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.
15. 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.
16. 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 Cosmetics Act (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.
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.
17. 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.
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.
Central Drugs Standard Control Organization (CDSCO), New
Delhi, coordinates the program. The Honorable Minister of Health, Dr.
Anbumani Ramadass at New Delhi, officially launched the program
on November 23, 2004.
