63 Regulatory requirements for outsourcing sterilization activity of medical devices by a manufacturer under Medical Device Rules 2017 2025-Jun-24 713 KB

Dr. Rajeev Singh Raghuvanshi Drugs Controller General (India) W ! Central Drugs Standard Control Organisation Ministry of Health & Family Welfare Government of India FDA Bhawan, Kotia Road New Delhi-110002 (India) tS TR S Zf T^C R
c|jei||U| W c R I W f, cFlScfl ^•feccft-110002 F. No. DC-DT-13011(11)/1/2025-eoffice Comp. No. 21508 Dated: 2 8 APR 2025 To All Members of DTAB

Subject: Minutes of the 92nd meeting of the Drugs Technical Advisory Board

(DTAB) held on 24.04.2025 through Hybrid mode. Sir/Madam, 92nd meeting of Drugs Technical Advisory Board was held on 24.04.2025 through Hybrid mode. The minutes of the 92nd meeting of Drugs Technical Advisory Board duly approved by the Chairman, is annexed for your information please. Yours faithfully, Dr. F anshi Drugs India) . . >TAB) Enel: Minutes of meeting Copy to:

1. PPS to DGHS, MoHFW, Nirman Bhawan, New Delhi
2. PS to JS(R), MoHFW, Nirman Bhawan, New Delhi Tel.: +91-11-23236965 Fax : +91-11-23236973 Email: dci@nic.in Website : www.cdsco.gov.in

Minutes of 92nd DTAB meeting held on 24.04.2025 PART-B (Related to Medical Devices) Agenda No. 20 Consideration of the proposal for no requirement of loan license application for sterilization purpose by a manufacturer, who has license in Form MD-3/4 or in Form MD-9/10, at the sterilization site having valid license for sterilization in Form MD-3 or Form MD-9 The Board was apprised about the DCC sub-committee report and DTAB agreed with the recommendation of the sub-committee subject to inclusion of an appropriate mechanism for submission of documentary evidence to the Licencing Authority in support of proper sterilization of product, at the time of seeking manufacturing licence subject to the condition that the license number of the sterilization site should be mentioned on label of the device.