All medical devices under the Drugs and Cosmetics Act and Medical Devices Rules to soon be covered under the ambit of “Drugs”; MOHFW issues a draft notification and invites comments and suggestions by 18th November, 2019
The Ministry of Health and Family Welfare (“Department”), through a draft notification dated 18th October 2019, has proposed to notify all the medical devices under Drugs and Cosmetics Act, 1940 (“Drugs and Cosmetics Act”) in order to regulate them as per the provisions of the Drugs and Cosmetics Act and the Medical Devices Rules, 2017.
The Department has decided to solicit suggestions / comments / objections from the public stakeholders with regard to the draft notification before its finalization.
The suggestions / comments / objections may be forwarded within 18th November, 2019 by email at firstname.lastname@example.org or by post to Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Room no. 414A, D Wing, Nirman Bhawan, New Delhi – 110011.
The Central Government, after consultation with the Drugs Technical Advisory Board, proposes to include the following devices intended for use in human beings or animals as drugs with effect from the 1st December 2019.
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 –
- Diagnosis, prevention, monitoring, treatment or alleviation of any diseases or disorder;
- Diagnosis, monitoring, treatment or alleviation or assistance for, any injury or disability;
- Investigation, replacement or modification or support of the anatomy or of a physiological process;
- Supporting or sustaining life.
- Disinfection of medical devices; and
- Control of conception.