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?Medical device? means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the specific purposes of:
? Diagnosis, prevention, monitoring, treatment or alleviation of disease
? Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
? Investigation, replacement, modification, or support of the anatomy or of a physiological process.
? Supporting or sustaining life.
? Control of conception.
? Disinfection of medical devices.
The growing sophistication and prevalence of medical devices have heralded the need for more stringent and well-defined
regulations. The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities.
For e.g., legal terms and their meanings are sometimes non-uniform even within one regulatory system. The regulation of
medical devices has developed much more slowly than that of medicines, which commenced in the late 1960s as a response to
the thalidomide tragedy. The knowledge and compliance with regulatory requirement is a key to success in development and
marketing of medical devices. High quality and well-designed medical devices are necessary to provide safe and effective clinical
care for patients as well as to ensure the health and safety of professional and lay device users. The present work reviews how
governments can fulfil part of their duties through the implementation of regulations.
Shashikanth.D is a student of JSS College of Pharmacy, JSS University, Mysore, Karnataka, India. He has completed his B Pharm from JSS College
of Pharmacy, Mysore during the year 2011. Presently he is pursuing M Pharm in Pharmaceutical Quality Assurance in JSS College of Pharmacy,
Mysore. He has attended various National and International Conferences. His current areas of interest are Quality Assurance, Regulatory Affairs,
Quality Management Systems, GMP Auditing, analytical method development of novel drugs.
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