Health Ministry to bring all Medical Devices under CDSCO regulations, Invites comments

Once finalized, the medical device makers will have to get licences from the Drug Controller General of India (DCGI) while CDSCO will be the nodal authority to investigate the quality, safety-related failure, complaints and can suspend the registration based on the outcome of the investigation.

New Delhi: Through a recent notification, the Union Health Ministry has proposed to bring all medical devices including contraceptives and implants under the regulatory framework of the apex drug regulatory body, Central Drugs and Standard Control Organisation (CDSCO), mandating all medical devices to get CDSCO certification.

In this regard, the government has sought comments from all stakeholders within 30 days before the draft notification is finalized, in the draft notification the timeline for implementation is December 1. The suggestions/comments/objections may be forwarded within 30 days from the date of issue of this Notice by email at drugsdiv-mohfw@,gov.in or by post to Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Room No. 4I4A, D Wing, Nirman Bhawan, New Delhi

Only the suggestions/comments/objections received on the above email/address within the period of 30 days shall be taken into consideration for finalization of the notification, the notification added

The proposal is under pursuance of sub-section (b) of section 3 of the Drugs and Cosmetics Act, 1940 to regulate them as per the provisions of Medical devices Act and Medical Devices Rules, 2017 framed thereunder.

Sub-section (b) of section 3 of the Drugs and Cosmetics Act, 1940 talks about all substances considered as "DRUGS".

Medical Dialogues had earlier reported, in a significant move to provide safety to patients and regulate the quality of diagnostic and medical devices in India, the health ministry had notified eight medical equipment, including all implantable devices, as "drugs" under Section 3 of the Drugs and Cosmetics Act, effective from April 1, 2020.

Also Read: Eight medical devices including CT, MRI, X-ray notified as DRUGS by health ministry

The recent draft notification dated October 18, 2019, stated;

In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December, 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 -

• diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;


• diagnosis, monitoring, treatment, 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.

In this regard, the government has sought comments from all stakeholders within 30 days before the draft notification is finalized, in the draft notification the timeline for implementation is December 1.

Once finalized, the medical device makers will have to get licences from the Drug Controller General of India (DCGI) while CDSCO will be the nodal authority to investigate the quality, safety-related failure, complaints and can suspend the registration based on the outcome of the investigation.

The move will help enforce standards to ensure the safety and effectiveness of these products while its pricing regulator, the National Pharmaceutical Pricing Authority (NPPA) will monitor the prices.

Also Read: PIL against Health Ministry notifying 8 medical devices as DRUGS, Delhi HC seeks Centre reply