Title:Medical Device Rules - 2017, India: An Insight
VOLUME: 7 ISSUE: 2
Author(s):Damini Sharma and Amrish Chandra *
Affiliation:Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh
Keywords:Medical device, regulation reforms, registration requirement, national regulatory authority,
diagnosis, surgical dressings.
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.
