CDSCO proposes to include Surgical Gowns and Drapes under the purview of the Drugs and Cosmetics Act, 1940 as Medical Devices

Dec 03, 2018 | by Avantis RegTech Legal Research Team

The Ministry of Health and Family Welfare had notified the Medical Devices Rules, 2017 vide G.S.R. 78(E) dated January 31, 2017 under the provisions of the Drugs and Cosmetics Act, 1940.

At present, 15 notified medical devices are regulated under the said Act. In the meeting held on October 05, 2018 with reference to the implementation of the decisions taken by Committee of Secretaries (Cos) on Technical Textiles, it proposed that surgical gowns and drapes can be considered for notification under the said Act.  Therefore, Central Drugs Standard Control Organisation (CDSCO) has published a notice issued on November 27, 2018 proposing to include surgical gowns and drapes under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 pertaining to such devices which are intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.

All the stakeholders are requested to forward their comments/suggestions within 45 days of issue of this notice through email at [email protected] and [email protected] or in hard copies to the office of DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002.

[No. 29/Misc/03/2018-DC (331)]




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