A foreign manufacturing establishment is required to register

Was formally 'Foreign Manufacturer Accreditation' under the PMD Act (a bit easier) now it is registration

Fairly simple process, mostly administrative declarations, information about the facility, etc.

Similar to the FDA Establishment Registration process

MAH or DMAH will submit a FMR application to PMDA

Certificate of FMR is valid for 5 years

Renewal applications must be submitted no later than 5 months prior to expiration of the current certificate

Any product imported after the FMR expires technically needs to be recalle

When a registered foreign manufacturer makes changes in the following matters, FMR Change Notification must be submitted to the PMDA in a timely manner within 30 days.

Name or address of the person responsible for the manufacturing establishment;

Name of the executives responsible for the services, when the manufacturer is a corporation:

Name of the manufacturing establishment;

Major part of buildings and facilities of the manufacturing establishment;

Category and (deemed) accreditation number, when a foreign manufacturer obtains additional accreditation for another category, or discontinues operation of their accredited manufacturing establishment.