The Medical Devices Introductory Course 2020

Medical Device Regulation - Japan

Regulatory Pathway Review Timeframes (estimated):

• Class I Notification = no review (immediate notification)

• Third-party Certification Standard review (Class II, some Class III) – typically 4-10m

• Pre-market approval for “Me-too” devices (Class III-IV, “Approval Standards” exist / apply) – typically (6-)12m

• PMA for New Medical Device (Class II-IV) – typically 12-24m, (revised PAL targets to reduce to 6-12m; fees approx. £67-92K * )

• Partial Change Registration (Class II – IV) – typically 3-6m

*2019 data

Medical Device Regulation - Japan

• Marketing Authorisation Holder (MAH) in Japan must obtain product registrations and hold contracts / agreements with device / component suppliers

• MAH required to have 3 responsible directors covering Marketing Authorisation (marketing), safety and quality aspects

• Quality System and GMP (import) requirements exist covering inspections of MAH, manufacture, distribution and warehousing

• Foreign manufacturers of devices and components are required to have Foreign Manufacturer Registration (suggest use Designated MAH if have no or limited presence in Japan)

• Clinical Studies – often required for new medical device registrations; “foreign” studies accepted (if meet Japanese GCP)

• Adverse Incident reporting required on a trending / change / unexpected basis (not for expected incidents arising within expected rates of occurrence)

The Organisation for Professionals in Regulatory Affairs