Guidance, Law & Regulations
No.
Title
Date
1
Regulations Governing the Classification of Medical Devices
2022-04-14
2
Guidance for Industry to Register Artificial Intelligence_Machine Learning - Based Software as Medical Device (AI_ML-Based SaMD)
2021-08-17
3
Guidance for Industry on Management of Cybersecurity in Medical Devices(TFDA)
2021-05-05
4
Regulations on Good Clinical Practice for Medical Devices
2021-05-01
5
Regulations Governing Commission of Medical Devices Management and Accreditation of Commissioned Institution
6
Regulations Governing Border Inspection and Examination of Imported Medical Devices
7
Regulations for Medical Device Recalls
8
Regulations for Management of Medical Device Safety Surveillance
9
Regulations for Management of Medical Devices Technicians
10
Regulations of Medical Device Tracking Management