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.
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.
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).
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 .
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
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
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
IMRDA The regulationWill 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
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.
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
Catheters Intra ocular lenses Drug eluting stents i.v.cannulae Bone cement Heart valve Scalp vein sets Orthopedic implant Internal prosthetic replacement
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
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.
ROLE OF PHARMACIST IN REGULATION ONUSE 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.
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.
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.