Recent J-MAF updates...

2024.11.11

Sakigake (Breakthrough) Designation in Japan

2024.10.28

Orphan Designation in Japan

2024.12.9

Technology Focus Series: Regenerative Medicine & Cellular Therapy Market Access

2024.12.23

Technology Focus Series: Guiding Catheter Market Access

2025

2025.1.14

Examples of the New Economic Efficiency Premium

2024

2025.1.28

Technology Focus Series: Occluder Device Market Access

2025.3.21

Medical Device HTA Decisions in Japan (as of March 2025)

2025.2.28

Reimbursement of New Medical Devices Through Procedure Fees in Japan

Recent Reimbursement Decisions for Japan

15

11

Reimbursed medical devices that received a premium since April 2024*

New reimburse decisions for medical devices since April 2024*

9

0

Reimbursed medical devices selected for HTA review since April 2024*

New reimbursement decision for in-vitro diagnostic (IVD) devices since April 2024*

Reimbursed in-vitro diagnostic (IVD) devices that received a premium since April 2024*

Reimbursed regenerative medicine products selected for HTA review since April 2024*

2

０

1

1

New reimbursement decisions for regenerative medicine products since April 2024*

Reimbursed regenerative medicine products that received a premium since April 2024*

*The Japanese government fiscal year is from April to March. Device figures represent unique devices that received a new functional category.

Recent new regenerative medicine & cellular therapy listings

Recent new in-vitro diagnostic diagnostics (IVD) listings

Recent new medical device listings

Resource Library

Device Reimbursement Premiums in Japan

LoPresti et al. (2024) provide a detailed analysis of how premiums were allocated for reimbursed devices in Japan between fiscal year 2015 and 2023.

HTA for Medical Devices in Japan

HTA assessments for reimbursed medical devices are detailed on the website for the C2H, Japan's HTA body.

Medical Device Reimbursement in Japan

Matsumoto et al. (2022) provide a detailed overview of the reimbursement process for medical devices in Japan.

Economics Evaluations for Medical Devices in Japan

In-Patient (DPC) Reimbursement in Japan

LoPresti et al. (2024) review economic evaluations for reimbursed devices in Japan between 2010 and 2023.

LoPresti et al. (2024) provide a detailed analysis of premiums associated with the prospective payment system for inpatient care in Japan for fiscal years 2018, 2020, and 2022.

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Key References

Other Useful References

Handbook of Health and Welfare Statistics, 2023

Pharmaceuticals and Medical Devices Agency website

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