Japan PMDA

Under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), foreign companies must be registered with the Ministry of Health, Labor, and Welfare (MHLW).

The FMR process involves an audit by Japanese regulatory officials from the Pharmaceutical and Medical Device Agency (PMDA). Document inspections sometimes, along with onsite inspections, are done. Each device design facility, main assembly plant, a domestic distribution center in Japan sterilizer should be registered.

The documents that need to be submitted:

Application for registration (Form 63-5)
Document stating applicants are not intoxicated or under the influence of illegal substances.
Curriculum vitae of the representative of the facility to be registered.
Drawings or maps of facility premises or areas.
If the PMDA requires a rare on-site inspection, only then will applicants need to submit manufacturing facility information like floor plans and production process flowcharts.

I. Pre-market submission (Todokede) Class I products can be registered via pre-market submission. No review or assessment is involved in this submission. This is a notification to PMDA.
II. Pre-market certification (Ninsho)
Class II (and a limited number of Class III) devices that have an associated certification standard (JIS) can be registered via pre-market certification. The registered certification body (RCB) is a third party involved in the assessment.
III. Pre-market approval (Shonin)
Class II and III devices without a specific certification standard, class IV devices are subject to the pre-market approval process.