| 1 | Guidance for Industry to Register Artificial Intelligence_Machine Learning - Based Software as Medical Device (AI_ML-Based SaMD) | 2021-08-17 |
| 2 | Guidance for Industry on Management of Cybersecurity in Medical Devices(TFDA) | 2021-05-05 |
| 3 | Regulations Governing Commission of Medical Devices Management and Accreditation of Commissioned Institution | 2021-05-01 |
| 4 | Regulations Governing Border Inspection and Examination of Imported Medical Devices | 2021-05-01 |
| 5 | Regulations for Medical Device Recalls | 2021-05-01 |
| 6 | Regulations for Management of Medical Device Safety Surveillance | 2021-05-01 |
| 7 | Regulations for Management of Medical Devices Technicians | 2021-05-01 |
| 8 | Regulations of Medical Device Tracking Management | 2021-05-01 |
| 9 | Regulations for Reporting Serious Adverse Events of Medical Devices | 2021-05-01 |
| 10 | Regulations on Good Clinical Practice for Medical Devices | 2021-05-01 |