Japan Medical Device Regulations

Agency
All medical devices are regulated by Pharmaceuticals and Medical Devices Agency (PMDA) as part of Ministry of Health, Labour and Welfare (MHLW)
Medical Device Definition
The term "medical device" as used in this Law refers to medical appliances or instruments (excluding regenerative medicine products) intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure and functions of the bodies of humans or animals, as specified by Cabinet Order
Classification of Medical Device
International ClassificationRisk base Medical Device ClassificationClassificationRisk LevelType of regulation
Class IDevices 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 techniqueGeneral Medical DeviceExtremely lowApproval/certification not required (Notification/self declaration)
Class IIDevices with relatively low risk to the human body in case of problems Ex) MRI devices, electronic endoscope, catheter for digestive organs, ultrasonic devices, dental alloyControlled Medical DeviceLowCertification by third party certificationApproval by the MHLW (reviewed by PMDA)
Class IIIDevices with relatively high risk to the human body in case of problems Ex) Dialyzer, bone prosthesis, mechanical ventilationSpecially Controlled Medical Device

Medium / High
Class IVDevices 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)

Premarket Approval Process
Class IClass II (Specified-Controlled)Class II (Controlled)Class IIIClass IV
Notification by PMDACertification by Registered Certified Body (RCB)Approval by MHLW
Application for product notification to PMDAApplication for product verification to RCBSummary Technical Document (STED) to PMDA
Quality Management System (QMS) requirement submission to PMDA or RCB
Notes
  • Device registrations do not expire
  • All document should be written in Japanese
  • Registration will generally take 1-3 years

Source: The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices (Tentative translation)
Pharmaceuticals and Medical Devices Agency site

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