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THE PHARMA REVIEW (MAY JUNE 2020)

Medical Device: Classification and Nomenclature

Dr. Balamuralidhara. V, Kaushik Devaraju & Sara Jabeen

Introduction: The enormous demand and dependency on the medical device are substituting the pharmaceutical form in a very gradual manner. As the number of devices is increasing with associated loads of diversity and sophistication due to which rigorous regulatory standards has emerged with time to time changes to the framed regulation or coming up with new regulations. The regulated markets, IMDRF as well as the developing markets have framed their own regulations to make sure that the diverse devices do not harm the patient for which the regulatory agencies decided to classify the medical devices based on their risk but yet times they fail to classify properly (example: Drug Eluting Stent). The classification of medical device protects from unlikely risk, danger or injury and also decides the effectiveness and performance of the medical device and should properly regulated. Therefore, the current paper discusses the classification system and rules opted for medical devices by various countries.

 

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THE PHARMA REVIEW (May - June 2020)

Medical Device: Classification and Nomenclature

Dr. Balamuralidhara. V, Kaushik Devaraju & Sara Jabeen

Introduction:
The enormous demand and dependency on the medical device are substituting the pharmaceutical form in a very gradual manner. As the number of devices is increasing with associated loads of diversity and sophistication due to which rigorous regulatory standards has emerged with time to time changes to the framed regulation or coming up with new regulations. The regulated markets, IMDRF as well as the developing markets have framed their own regulations to make sure that the diverse devices do not harm the patient for which the regulatory agencies decided to classify the medical devices based on their risk but yet times they fail to classify properly (example: Drug Eluting Stent). The classification of medical device protects from unlikely risk, danger or injury and also decides the effectiveness and performance of the medical device and should properly regulated. Therefore, the current paper discusses the classification system and rules opted for medical devices by various countries.

For full text of this article contact the publisher on kongposhpub@gmail.com

Go to Content Index Page

PHARMA REVIEW - ARTICLES ARCHIVE (COMPLETE LIST)

The above content is an abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate, New Delhi, India -110016
Tel.: 011 4142 0016, Mob: 98111 95411
Email: kongposhpub@gmail.com, Website: www.kppub.com