70 Circular regarding submission of PSUR of Medical devices/ IVD through Medical Devices Portal 2024-Mar-19 475 KB
In force — no superseding record on file.
File No.: PSUR-13011(15)/1/2024-eoffice Government of India Directorate General of Health Services Central Drugs Standard Control Organization (PSUR/PV/AEFI Division) CIRCULAR FDA Bhawan, Kotla Road, New Delhi- 100002 Dated: / 9 MAR 2024
Subject: Submission of online applications of PSURs w.r.t Marketing Authorization
(MA) of Medical Devices/ In-vitro Devices- Reg. In order to streamline the regulatory submission procedure, the submission of applications of PSURs' (Periodic Safety Update Reports) w.r.t Marketing Authorization of Medical Devices/ In-vitro Devices is functional now through Online System for Medical Devices portal at https://www.cdscomdonline.gov.in/. All applicants submitting PSURs' shall apply through Online System for Medical Devices as per checklist in the Portal. The facility of offline submission of applications in hard copy or any other mode will not be available for processing from 01.04.2024. To:
- All Stake holders through COSCO website
- All Zonal/Sub-Zonal offices of COSCO
- CRU Section of CDSCO(HQ)
- CDAC Team (Dr. ajeev ingh Raghuvanshi) Drugs Cont oller General (India)
Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 24580 --apply.