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16 documents matching

October 2023
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · 2023-10-12
142 Clarification on the Circular no. 29/Misc/03/2023-DC(344) dated 12.10.2023 2023-Oct-12 22 KB
Clarification on the Regulation of all Class C & D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R. 102(E) dt 11.02.2020- Regarding.
April 2023
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · 2023-04-12
155 Circular for Licensing of Class C D medical devices dated 12.04.2023 2023-Apr-12 310 KB
October 2022
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · 2022-10-01
169 Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as per G.S.R. 102(E) dt 11.02.2020 2022-Sep-30 401 KB
January 2013
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · 2013-01-15
156 Clarification w.r.t. the new drug status of FDCs (Fixed Dose Combinations) which were scrutinized w.r.t. letter dated 15.1.2013 issued by this office and declared as rational 2023-Apr-05 22146 KB
Procedure to be followed for Subsequent applicant in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I)-regarding.
Undated
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
84 Submission of clinical trial site addition and change of principal Investigator applications through sugam portal 2025-Feb-24 57 KB
Submission of Clinical Trial Site Addition and change of Principal Investigator applications through SUGAM portal
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
188 Procedure to be followed for regularization of FDCs with respect to 294 FDCs examined' by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval
Procedure to be followed for regularization of FDCs with respect to 294 FDCs examined: by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I)regarding.
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
78 Draft risk based classification list Cardiovascular and Neurological dated 01 04 2025 for stakeholder comments 2025-Apr-01 1014 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
46 Separate provision for subsequent Importer in Online system for Medical Devices 2025-Sep-15 477 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
29 SoP - Compounding of Offences Rules, 2025 2026-Jan-01 2395 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
87 Procedure to be followed for subsequent applicant in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I) 2025-Feb-04 3922 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
189 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017 2022-Mar-16 813 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
67 Guidance document on disposal of expired/ unused drugs 2025-May-27 588 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
28 Guidelines on Compounding of Offences under the Drugs and Cosmetics Act, 1940 as per Drugs and Cosmetics (Compounding of Offences) Rules, 2025 2026-Jan-01 765 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
148 FAQS ON IMPLEMENTATION OF GSR 823(E) DATED 17TH NOVEMBER, 2022 WITH RESPECT TO BAR CODE OR QR CODE ON TOP 300 BRANDS 2023-Jul-25 28 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
27 FAQs on Drugs and Cosmetics (Compounding of Offences) Rules, 2025 2026-Jan-01 368 KB
IN FORCE Procedural & compliance ·? CDSCO · Public Notice · undated
104 Circular- Testing and evaluaion of Medical Devices/ In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country 2024-May-29 429 KB