MoHFW issues Draft Notification to notify various medical devices to be regulate as per the provisions of the Drugs and Cosmetics Act, 1940 and medical Devices Rules, 2017

Oct 18, 2019 | by Avantis RegTech Legal Research Team

The Ministry of Health and Family Welfare (MoHFW) on October 18, 2019 has issue Draft Notification to notify all the medical devices under section 3(b) of the Drugs and Cosmetics Act, 1940 which defines Drugs, to regulate them as per the provisions of the Act and Medical Devices Rules, 2017 with effect from December 01, 2019 namely:

All devices including an instrument, apparatus, appliance, implant, material or other article; whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of:

(i)          Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;

(ii)         Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;

(iii)          Investigation, replacement or modification or support of the anatomy or of a physiological process;

(iv)               Supporting or sustaining life;

(v)                Disinfection of medical devices; and

(vi)               Control of conception

However, suggestions/ comments/ objections may be forwarded within 30 days from the date of issue of this Notice by email at [email protected] or by post.


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