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Market Information
Japan ’s healthcare expenditure amounted to approximately 43 trillion Japanese yen in the fiscal year 2020, an increase from around 38.6 trillion Japanese yen in fiscal 2011.
Market Trend: Japan's statutory health insurance system (SHIS) provides coverage for 98.3% of the population, with the remaining 1.7% covered by the distinct Public Social Assistance Program designed for impoverished individuals.
The projected compound annual growth rate for Japan’s medical equipment market between 2022 and 2027 is estimated to be 4.1% in local currency terms and 6.9% in US dollar terms.
After the Cabinet meeting approved the Reorganization and Rationalization Plan for Special Public Corporations in 2001, the Pharmaceuticals and Medical Devices Agency (PMDA) was created. This agency commenced operations on April 1, 2004, established under the Law for the Pharmaceuticals and Medical Devices Agency. It amalgamated the functions of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and a segment of the Japan Association for the Advancement of Medical Equipment (JAAME).
Medical Device Regulation
Pharmaceuticals and Medical Devices Agency (PMDA), under the MHLW.
Classification, Fees, Timeline
DEVICE CLASS | FEES | TIMELINE |
|---|---|---|
Class I | N.A. | 1 week |
Classes II, III & IV | $20,000 - $120,000 | 6 to 36 months |
Product Registration Routes
DEVICE CLASS | CONDITIONS |
|---|---|
Class I | Notification to the PMDA |
Class II | Certification by registered certification body |
Class II (Others) | Approval of the MHLW |
Class III | Certification by registered certification body |
Class III (Others) | Approval of the MHLW |
Class IV | Approval of the MHLW |
Useful Information
Validity of License: 5 years.
License transfer: Change of Registration application needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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