Medical Device Rules - 2017, India: An Insight

(E-pub Ahead of Print)

Author(s): Damini Sharma*, Amrish Chandra.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

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Abstract:

According to “Medical Device Rules-2017” (MDR-2017), “Medical devices (MD) are the substances 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”(1). MD in these rules are classified into four classes: - class A, class B, class C and class D(1). The purpose of this review article is to present an overview of the regulatory registration requirement of MD in India according to new MDR-2017.

Keywords: Medical device, Medical Device Rules , India

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Article Details

(E-pub Ahead of Print)
DOI: 10.2174/2666255813666190912114043

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