| 1 |
Draft Guidance document for Manufacturers of In-vitro diagnostic Medical device for stakeholders comment |
2026-Oct-09 |
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1567 KB |
| 2 |
Surrender of Cosmetic Registration Certificate No. RC/COS-005067 dated 05.07.2024 |
2026-Oct-06 |
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340 KB |
| 3 |
Public Health alert against the use of unauthorised Cosmetics Products |
2026-Sep-14 |
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1090 KB |
| 4 |
Drug Regulatory and Law Enforcement Agencies Intensify Coordinated Action Against Illegal Manufacture and Distribution of Misbranded Drugs |
2026-Sep-05 |
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2.3 MB |
| 5 |
cancellation order dated 24.08.2026 (Skintle Enterprises Pvt Ltd) |
2026-Sep-01 |
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683 KB |
| 6 |
Clinical Trial Applications (Phase I, Il and III) for Cell and Gene Therapeutics Products through SUGAM Online portal system |
2025-Jul-09 |
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2877 KB |
| 7 |
Dircction under section 33P of the Drugs & Cosmetics Act, 1940 for issuance of clarification on stem cell derived products' as defined under New Drugs and Clinical Trials Rules, 2019 |
2021-Feb-09 |
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928 KB |
| 8 |
Stem Cell Treatment and Advertisements for various diseases |
2023-Oct-12 |
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1122 KB |
| 9 |
Inviting comments on standard IVD evaluation draft protocols Scrub Typhus drafted by ICMR and CDSCO |
2026-Jul-13 |
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1.90MB |
| 10 |
Testing Laboratories approved by Statas & UT in Form 37 of Drugs Rule 1945 and Cos 23 of Cosmetics Rule 2020 |
2026-Mar-10 |
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455 KB |
| 11 |
Manufacturing and marketing of un-approved drug products containing Enclomiphene and its combinations |
2026-Aug-11 |
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588 KB |
| 12 |
Stakeholder Consultation on Operational Guidelines for Single Ethics Committee Review of Multi-Centre Research in India |
2026-Aug-06 |
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320 KB |
| 13 |
Regulatory Alert regarding Cancellation of Registration Certificates of Ethics Committees under the New Drugs and Clinical Trials Rules, 2019 |
2026-Jul-24 |
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96 KB |
| 14 |
Surrender of cosmetic Registration Certificate No. RC/COS-003938 dated 23.08.2023 |
2026-Jul-23 |
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359 KB |
| 15 |
Surrender of Cosmetic Registration Certificate No RC/COS-002707 dated 06-Oct. 2021 and RC/COS-002885 dated 3-Jan-2022 |
2026-Jul-21 |
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364 KB |
| 16 |
Surrender of Cosmetic Registration Certificate No RC/COS-002497 daled 08-Jul- 2021 |
2026-Jul-21 |
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348 KB |
| 17 |
Guidance document on Medical Device Software under MDR-2017 |
2026-Jul-21 |
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1589 KB |
| 18 |
Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022 |
2022-Oct-21 |
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290 KB |
| 19 |
The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded in 2025 |
2025-Oct-22 |
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367 KB |
| 20 |
Separate provision for subsequent Importer in Online system for Medical Devices |
2025-Sep-15 |
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477 KB |
| 21 |
Provision for auto-generated Market Standing Certificate and Non-Conviction Certificate for licenced medical device |
2025-Apr-09 |
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307 KB |
| 22 |
Circular- Testing and evaluaion of Medical Devices In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country |
2024-May-29 |
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429 KB |
| 23 |
List of Notified Bodies registered with CDSCO under MDR, 2017 |
2023-Apr-03 |
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830 KB |
| 24 |
Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer |
2022-Dec-22 |
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412 KB |
| 25 |
Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021 |
2020-Dec-28 |
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334 KB |
| 26 |
Clarification regarding import of diagnostic kits reagents for Research use only ROU for academic research purpose |
2020-Jun-19 |
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368 KB |
| 27 |
Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices |
2017-Oct-31 |
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666 KB |
| 28 |
NOTICE regarding not of Standard Quality of Mediclone D |
2017-Sep-15 |
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60 KB |
| 29 |
NOTICE regarding Not of Standard Quality Combipack ABD |
2017-Sep-15 |
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73 KB |
| 30 |
corrigendum with respect to revised specification criteria of acceptance for quality test for Ant-HCV Rapid Kit |
2017-Jul-12 |
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42 KB |
| 31 |
NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi |
2017-Apr-24 |
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38 KB |
| 32 |
Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagent |
2016-Feb-16 |
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55 KB |
| 33 |
Letter to All state, UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue |
2015-Feb-14 |
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295 KB |
| 34 |
Provision for Risk Classification of In-Vitro Diagnostic Medical Devices on the CDSCO Online System for Medical Devices |
2026-Feb-06 |
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132 KB |
| 35 |
Inviting comments on consideration of the proposal regarding Issue of use of brand name extensions by the pharmaceutical firms |
2026-Jul-06 |
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53 KB |
| 36 |
CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29/06/2026 |
2026-Jun-29 |
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661 KB |
| 37 |
Submission of Post Approval Changes Applications of Registration Certificate and Import Licence of Human Vaccines and Anti-sera through SUGAM Portal |
2026-Jun-24 |
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477 KB |
| 38 |
Sale of In-Vitro Fertilization media, reagents and related consumables used in Assisted Reproductive Technology procedures |
2026-Jun-24 |
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323 KB |
| 39 |
List of Debarment of Principal Investigators by CLA |
2026-Jun-12 |
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2691 KB |
| 40 |
List of Suspended Ethics Committee by CLA |
2026-Jun-12 |
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1584 KB |
