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Guidance, Law & Regulations

1Guidance for Industry to Register Artificial Intelligence_Machine Learning - Based Software as Medical Device (AI_ML-Based SaMD)2021-08-17
2Guidance for Industry on Management of Cybersecurity in Medical Devices(TFDA)2021-05-05
3Procedure for Reporting Severe Adverse Reactions to Medicines2018-11-22
4Pharmaceutical Affairs Act2018-10-22
5Pharmaceutical Affairs Act Enforcement Rules 2018-10-21
6Regulations for Governing the Management of Medical Device2018-10-20
7Regulations for Registration of Medical Device2018-10-19
8Guidelines for Registration of In Vitro Diagnostic Medical Device2018-10-18
9Standards of Review Fees for the Registration of Western Medicines and Medical Devices 2018-10-17
10Regulations for Approval of Specific Medical Products’ Manufacturing or Importing as a Special Case 2018-10-16
Total Records:12 Current Page No:1/ 2