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Regulations

Total 20 Articles, Current Page : 1/2
Regulations on Labelling, etc. of Medical Devices
Regulations on Labelling, etc. of Medical Devices
Standards for Stability Testing of Medical Devices
Standards for Stability Testing of Medical Devices
Guidelines on the Products, Scope, Etc. of Entrusted Certification or Notification services for Medical Devices
Guidelines on the Products, Scope, Etc. of Entrusted Certification or Notification services for Medical Devices
Common Reference Standards for Biological Safety
Common Reference Standards for Biological Safety
Guidance for Certification, Notification, and Review of Medical Devices by Item Category
Guidance for Certification, Notification, and Review of Medical Devices by Item Category
Guidance for Approval and Review of Recognized Substantial Equivalent devices
Guidance for Approval and Review of Recognized Substantial Equivalent devices
Guidance for Approval and Review of Custom Devices manufactured using 3D printers
Guidance for Approval and Review of Custom Devices manufactured using 3D printers
Guideline for Approval and Evaluation of In Vitro Companion Diagnostic Devices
Guideline for Approval and Evaluation of In Vitro Companion Diagnostic Devices[OCT 2015)
Standards for Manufacture, and Quality Management of Medical Device
Standards for Manufacture, and Quality Management of Medical Device[Attached Table 2, July 2015)]
ENFORCEMENT REGULATIONS OF THE MEDICAL DEVICE ACT
ENFORCEMENT REGULATIONS OF THE MEDICAL DEVICE ACT[Ministerial Decree Number18 of the Ministry of Health and Welfare, Effective as of September 1, 2010, and Amendment of Other Laws]