The Central Drugs Standard Control Organisation {“CDSCO”} (Medical Devices and Diagnostics Division) has, in a notice issued on 27th November, 2018 proposed to include surgical gowns and drapes under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 (“Act”) 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.
CDSCO has invited comments and suggestions on the same from the stakeholders. Comments and suggestions, if any, should be submitted through email at dci@nic.in and ddcimd-cdsco@nic or in hard copies to the office of DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002, within 11th January, 2019.
Background
The Ministry of Health & Family Welfare, Government of India had notified the Medical Devices Rules 2017 on 31st January, 2017 under the provisions of the Act. Presently, 15 notified medical devices are regulated under the Act.
Thereafter, in a meeting held on 5th October, 2018 at Nirman Bhawan, New Delhi under the chairmanship of Directorate General of Health Services, it was proposed that surgical gowns and drapes could be considered for notification under Section 3 (b) (iv) of the Act as ‘Medical Devices’.
Source: Central Drugs Standard Control Organisation
