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Regulations

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Regulation on Designation and Operation of Industry Standards Development Cooperation Institutes, Etc.
Regulation on Designation and Operation of Industry Standards Development Cooperation Institutes, Etc.
Standard Specifications of Medical Devices
Standard Specifications of Medical Devices
Common Standards and Specifications on Electromechanical Safety of Medical Device
Common Standards and Specifications on Electromechanical Safety of Medical Device
Common Standards and Specifications on Biological Safety of Medical Devices
Common Standards and Specifications on Biological Safety of Medical Devices
Common Standard Specification on Electromagnetic Safety of Medical Devices
Common Standard Specification on Electromagnetic Safety of Medical Devices
Regulation on Prior Review of Advertisement on Medical Device
Regulation on Prior Review of Advertisement on Medical Device
Regulation on Management of Safety Information Including Medical Device Side Effects, Etc.
Regulation on Management of Safety Information Including Medical Device Side Effects, Etc.
Regulation on Reporting Production, Export, Import and Repair Performances of Medical Devices
Regulation on Reporting Production, Export, Import and Repair Performances of Medical Devices
Medical Device Good Manufacturing Practices
Medical Device Good Manufacturing Practices
Regulation on Medical Device Re-evaluation
Regulation on Medical Device Re-evaluation