Medical Device Rules - 2017, India: An Insight

Author(s): Damini Sharma, Amrish Chandra*

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 2 , 2020

Graphical Abstract:


According to “Medical Device Rules-2017” (MDR-2017), “Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant and substances including mechanical contraceptives, disinfectants and insecticides and devices notified from time to time under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940”. According to this definition, MDs are classified into four classes: - class A, class B, class C and class D. The purpose of this review article is to present an overview of the regulatory registration requirement of MD in India according to the new MDR-2017.

Keywords: Medical device, regulation reforms, registration requirement, national regulatory authority, diagnosis, surgical dressings.

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Article Details

Year: 2020
Page: [126 - 134]
Pages: 9
DOI: 10.2174/2666255813666190912114043

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PDF: 19