The Medical Devices Introductory Course 2020

Medical Device Regulation - Japan

• Medical Device Designation: • Certain products may not be classed as medical devices but as “general merchandise” • Classification: use JMDN code [risk-based GHTF classification if no JMDN code] • Class I - “General medical devices” (low risk, eg: scalpel, x-ray film) • Class II - ”Controlled medical devices” (medium risk, e.g.: MRI, GI catheters) • Class III – “Specially Controlled medical devices” (high risk, eg: artificial bones, dialysers) • Class IV - “Specially Controlled medical devices (high risk / highly invasive, eg: pacemaker, artificial heart valves )

Medical Device Regulation - Japan Regulatory Pathways:

• “Todokede” = Notification registration with MHLW / No pre- market approval / DoC (Essential principles) [Class I] • “Ninsho” = Controlled Devices for which there is a Certification Standard (in JMDN code) – submit for third party certification* [“me too” Class II (and some Class III generic)] • “Shonin” = Controlled Devices for which no Certification Standard exists or for new medium risk medical devices – submit for pre- market approval by MHLW [Class II / Class III] • “Shonin” = Also for Specially Controlled Devices and high risk devices submit for pre-market approval by MHLW [Class III novel / improved and (all) Class IV) • Note: ”Shonin” also required for Class I and Class II when no JMDN code! Use GHTF ”STED” format for all PMA submissions • Partial Change Registration – required for changes to approved devices

*Submit to a Registered Certification Body (similar to EU notified Body)