Patient access to medical devices-what about Japan, the second largest medical device market?

被引：1

作者：

Ikeno F. ^{[1
]}

Ikeda K. ^{[2
]}

Uchida T. ^{[3
]}

机构：

[1] Falk Cardiovascular Research Center, Stanford University, Stanford, CA, 94305-5406

[2] Tohoku University Hospital, Sendai

[3] Tokyo Women's Medical University, Tokyo

来源：

Cardiovascular Intervention and Therapeutics | 2014年 / 29卷 / 1期

关键词：

Device lag; HBD; Medical device; Regulatory science; Reimbursement;

D O I：

10.1007/s12928-013-0202-z

中图分类号：

学科分类号：

摘要：

Patients' access to innovative medical devices in Japan still shows the gap between the other countries. The cause of this device gap is researched from the prior published data. We searched the review time of new innovative devices by the Pharmaceuticals and Medical Devices Agency (PMDA) and the submission time lag compared with the US and EU from the prior published data. The average review time was 9.5 months and the total time from PMDA to introduction of the device to patients in Japan is almost similar to the US and the four European countries. However, the time lag of the file submission between Japan and the US was 2.42 years, on average, between 2001 and 2009. The review time for new innovative medical devices by the PMDA has been improving year after year. On the contrary, the pre-submission delay still exists in Japan. © 2013 Japanese Association of Cardiovascular Intervention and Therapeutics.

引用

页码：1 / 3

页数：2

共 50 条

[21] Medical device incidents reported to the BfArM - What do they tell us about deficiencies in instruction and training for medical device use?
Nowak, M.
Lange, K.
Lauer, W.
[J]. BIOMEDICAL ENGINEERING-BIOMEDIZINISCHE TECHNIK, 2014, 59 : S1208 - S1208
[22] CAPTURING PATIENT PERSPECTIVES IN THE EVALUATION OF MEDICAL DEVICES: THE CASE OF CENTRAL VENOUS ACCESS DEVICES IN CHEMOTHERAPY
Ryan, C.
Wu, O.
[J]. VALUE IN HEALTH, 2017, 20 (09) : A592 - A592
[23] PATIENT ACCESS NETWORK: MULTI-STAKEHOLDER SHARED POLICY STRATEGIES FOR MEDICAL DEVICE ACCESS
Di Brino, E.
Basile, M.
Rumi, F.
Antonini, D.
Fortunato, A.
Cicchetti, A.
[J]. VALUE IN HEALTH, 2023, 26 (12) : S274 - S274
[24] Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review
Beck, A. C. C.
Retel, V. P.
Bhairosing, P. A.
van den Brekel, M. W. M.
van Harten, W. H.
[J]. HEALTH POLICY, 2019, 123 (12) : 1185 - 1198
[25] Assurance of Software-Intensive Medical Devices: What About Mental Harm?
Luis de la Vara, Jose
Gallina, Barbara
Fernandez-Caballero, Antonio
Pascual Molina, Jose
Garcia, Arturo S.
Ayora, Clara
[J]. 2023 53RD ANNUAL IEEE/IFIP INTERNATIONAL CONFERENCE ON DEPENDABLE SYSTEMS AND NETWORKS - SUPPLEMENTAL VOLUME, DSN-S, 2023, : 168 - 172
[26] WHAT PHYSICIANS SHOULD KNOW ABOUT THE REGULATION OF OBSTETRIC AND GYNECOLOGIC MEDICAL DEVICES
YIN, L
[J]. JOURNAL OF REPRODUCTIVE MEDICINE, 1983, 28 (01) : 3 - 11
[27] WHAT THE CLINICAL CHEMIST SHOULD KNOW ABOUT FDA MEDICAL DEVICE AMENDMENTS
RICE, EW
[J]. CLINICAL CHEMISTRY, 1979, 25 (06) : 1149 - 1149
[28] ASSESSMENT OF THE MARKET ACCESS POTENTIAL OF A NOVEL MEDICAL DEVICE AND APP COMBINATION FOR AN ORPHAN DISEASE
Smith, L. A.
Mukku, S. R.
Ohanjanyan, A.
Awasthi, P.
[J]. VALUE IN HEALTH, 2018, 21 : S270 - S270
[29] Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan
Mochizuki, Makiko
Maeda, Hideki
[J]. FRONTIERS IN MEDICAL TECHNOLOGY, 2024, 6
[30] A Review of the Regulatory Framework for Initiation and Acceleration of Patient Access to Innovative Medical Products in Japan
Matsushita, Shunsuke
Tachibana, Keisuke
Nakai, Kiyohito
Sanada, Shoji
Kondoh, Masuo
[J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2019, 106 (03) : 508 - 511

← 1 2 3 4 5 →