| 1 |
Guidance document Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST) |
2025-Jan-16 |
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2642 KB |
| 2 |
Updation of exisiting risk based classification list_draft_dated 06 01 2025 for stakeholder comments |
2025-Jan-06 |
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3025 KB |
| 3 |
Inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO |
2025-Jan-02 |
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2843 KB |
| 4 |
Merged existing Medical Devices risk-classification |
2025-Jan-01 |
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18,028 KB |
| 5 |
Submission of Clinical Trial Site Addition and change of Principal Investigator applications through SUGAM Portal |
2024-Dec-30 |
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70 KB |
| 6 |
Reconstitution of Central Expert Committee to determine the quantum of compensation in respect of faulty ASR Hip implant manufactured by M/s. DePuy international Limited U.K now M/s. Johnson & Johnson Private Limited implanted in lndia |
2024-Dec-02 |
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331 KB |
| 7 |
MEDICAL DEVICE ADVERSE EVENT REPORTING FORM Version 1.2 |
2024-Oct-08 |
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656 KB |
| 8 |
Draft Guidelines on Good Clinical Practices |
2024-Sep-12 |
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3315 KB |
| 9 |
Baxter recall letter for Product Fibrin Sealant Kit Brand name Tisseel Lyo manufactured in Vienna Austria |
2024-Sep-02 |
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1508 KB |
| 10 |
Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2024 |
2024-Aug-30 |
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8 KB |
