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 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	Certification by third party certification	Approval by the MHLW (reviewed by PMDA)
Class IV	Devices highly invasive to patients and with life-threatening risk in case of problems Ex) Pacemaker, artificial cardiac valve, stent graft	Specially Controlled Medical Device	Medium / High	Approval by the MHLW (reviewed by PMDA)

Premarket Approval Process

Class I	Class II (Specified-Controlled)	Class II (Controlled)
Notification by PMDA	Certification by Registered Certified Body (RCB)	Approval by MHLW
Application for product notification to PMDA	Application for product verification to RCB	Summary 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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