Medical devices are defined under section 3, clause (b) of the Drugs and Cosmetics Act, 1940, along with drugs. It should be read with Rule 3 (zb) of the Medical Devices Rules 2017. Medical devices include both the substances (excluding drugs) and the devices which are notified and used for the medical purposes.
The difference between the medical device and drugs is that the medical device will not achieve its primary intended action in human beings and animals by means of any pharmacological, immunological or metabolic means but assist in its function by such means. However due to the advances in technology the difference between the drug and medical devices are blurring and the drug-device combination products are now commonplace. E.g. bone cements with antibiotics, catheters with heparin, etc.
Accordingly, medical device means-
(A) 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 covered under sub-clause (i),
(B) Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii),
(C) Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act.
The substances which are used for in vitro diagnosis are known as the in vitro diagnostic medical device. The medical device also includes the substances which are notified in the Official Gazette. This includes condoms, intrauterine devices, disinfectants, insecticides etc. The Central Government, after consultation with the Board (DTAB) may notify the devices in the Official Gazette.
The medical device will not achieve its primary intended action in human beings and animals by means of any pharmacological, immunological or metabolic means but may assist in its function by such means.
Pharmacological action is the interaction between the substance and the body along with a dose – response correlation. Immunological action refers to the stimulation or movement of cells or other products involved in specific immune pathway. Metabolic refers to an action that alters the normal chemical process in the
body.
Hi, this is a comment.
To get started with moderating, editing, and deleting comments, please visit the Comments screen in the dashboard.
Commenter avatars come from Gravatar.
Thanks forr finally writing abut > What is a Medical Device?
– Good Manufahturing Prractice in Indian context < Liked it!