Japan Medical Device Regulation
Regulatory Authority: Pharmaceuticals and Devices Agency (PMDA)
Regulation: Pharmaceutical and Medical Device Act (PMD Act)
Representative (should be based in country or not): Yes, Authorized Representative is required.
Registration timeline: between 1-3 years depending on the device classification.
Classification: Class I, II, III, IV
1. Foreign Manufacturer Registration (FMR):
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:
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.
2. After FMR, the medical device needs to be registered via MAH or DMAH. There are three regulatory pathways:
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.
Documents required for registration:
All documents submitted during the authorization procedure must be in Japanese.
The submission documents are based on the IMDRF’s internationally recognized STED format. In addition to the STED summary documents, the following annexes are required:
A – Development history (previous device versions, global authorizations)
B – Product specifications
C – Data on stability and shelf life
D – Compliance with the applicable standards and essential principles
E – Performance test data
F – Risk analysis
G – Manufacturing (process, supervision, sterilization)
H – Clinical data
Japan is one of the five Medical Device Single Audit Program (MDSAP) participants, along with Australia, Brazil, Canada, and the United States. Manufacturers need to follow MHLW Ordinance No. 169 related to a quality management system which is based on ISO 13485.
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