International Classification | Risk base Medical Device Classification | Classification | Risk Level | Type of regulation | |
---|---|---|---|---|---|
Class I | Devices with extremely low risk to the human body in case of problems Ex) In vitro diagnostic devices, steel made small devices (including a scalpel, tweezers), X-ray film, devices for dental technique | General Medical Device | Extremely low | Approval/certification not required (Notification/self declaration) | |
Class II | Devices with relatively low risk to the human body in case of problems Ex) MRI devices, electronic endoscope, catheter for digestive organs, ultrasonic devices, dental alloy | Controlled Medical Device | Low | Certification by third party certification | Approval by the MHLW (reviewed by PMDA) |
Class III | Devices with relatively high risk to the human body in case of problems Ex) Dialyzer, bone prosthesis, mechanical ventilation | Specially Controlled Medical Device | Medium / High | ||
Class IV | Devices highly invasive to patients and with life-threatening risk in case of problems Ex) Pacemaker, artificial cardiac valve, stent graft |
Approval by the MHLW (reviewed by PMDA) |