S.No | Document Number | Document Title | Doc Type | Priority | Language | Document Stage | Last Action Date |
---|---|---|---|---|---|---|---|
1 | MHD/19/15611 | In-vitro Diagnostic (IVD) Devices - Blood Gas Analyzers | New | 1 | English | PDF Sent To Technical Department | 07-06-2024 |
2 | MHD/19/15613 | In-vitro Diagnostic (IVD) Devices - Electrolyte Analyzer | New | 3 | English | Pdf from Department | 19-07-2024 |
3 |
MHD/19/21867 (Modified/Technically Equivalent To: ISO 10993-7:2019) |
Biological Evaluation of Medical Devices Part 5 Ethylene oxide sterilization residuals | New | 3 | English | Pdf from Department | 19-07-2024 |
4 |
MHD/19/22473 (Modified/Technically Equivalent To: ISO 10993-23:2021) |
Biological Evaluation of Medical Devices Part 7 Tests for irritation ISO 10993-23:2021 MOD | New | 3 | English | Ready for Gazette | 19-06-2024 |
5 | MHD/19/25234 | Blood Cell Counter Analyzer | New | 2 | English | Project-Approval | 11-04-2024 |
6 | MHD/19/25235 | Hemoglobin Analyzer | New | 2 | English | Project-Approval | 11-04-2024 |
7 |
MHD/19/25236 (Identical To: ISO/TS 37137-1:2021) |
Biological evaluation of absorbable medical devices Part 1: General requirements | New | 2 | English | Project-Approval | 11-04-2024 |
8 |
MHD/19/25237 (Identical To: ISO/TR 10993-33:2015) |
Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity | New | 2 | English | Project-Approval | 11-04-2024 |
9 |
MHD/19/25238 (Identical To: ISO/TR 10993-55:2023) |
Biological evaluation of medical devices Part 55: Interlaboratory study on cytotoxicity | New | 2 | English | Project-Approval | 11-04-2024 |