MEDICAL DEVICES

INTRODUCTIONA 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 .

IMRDAThe 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 PRINCIPLESShould not compromise health and safety Design and manufacture of devices must conform with

safety principlesLong term safety should be ensuredBenefits of the devices must outweigh any side effectsMedical devices should be useful for the intended purpose

IMRDA OBJECTIVESProvide notification of essential principlesProvide for risk based classification of devicesNotify standards and guidelines Provide mechanism of conformityProvide a post market surveillance systemProvide for enforcement

IMRDA The regulation

Will issue Design and manufacturing requirementsPerformance evaluationDemonstration of device standards , testing and

complianceRegulation of post marketing follow upRegulation of recallsLegislate and punishment for non compliancePrinciple of safety

IMRDA classificationClass 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 ActCovers 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 needlesDisposable hypodermic syringesDisposable 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 ActAdditionally following products are regulated as ‘Drugs’

under Drugs & Cosmetics Act & Rules there under:-Blood grouping seraLigatures , sutures & staplers Intra uterine devicesCondomsTubal ringsSurgical dressingsUmbilical cordBlood/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 ON USE OF MEDICAL DEVICESPharmacist 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.