Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children ―-Reference-Cited by-同舟云学术

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children ―

Published:2020-04-24 Issue:5 Volume:84 Page:786-791
ISSN:1346-9843
Container-title:Circulation Journal
language:en
Short-container-title:Circ J

Author:

Takahashi Sara¹,Ibrahim Nicole²,Yasukochi Satoshi³,Ringel Richard⁴,Ing Frank⁵,Tomita Hideshi⁶,Sugiyama Hisashi⁷,Yamagishi Masaaki⁸,Forbes Thomas J.⁹,Kim Sung-Hae¹⁰,Ho Mami¹,Gillette Nicole²,Nakamura Yasuko¹,Mineta Koji¹¹,Fearnot Neal¹²,Dineen Declan¹³,Vang Eric¹³,Haskin Russel¹⁴,Becker Lisa A. M.¹⁵,Sekiguchi Kazuaki¹⁶,Sakamoto Kisaburo¹⁰,Ruiz Carlos E.¹⁷,

Affiliation:

1. Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency

2. Division of Cardiovascular Devices, Office of Device Evaluation, Food and Drug Administration (FDA)

3. Nagano Children’s Hospital Heart Center

4. Johns Hopkins School of Medicine

5. UC Davis Children’s Hospital

6. Showa University Hospital Pediatric Heart Disease & Adult Congenital Heart Disease Center

7. Tokyo Women’s Medical University

8. Kyoto Prefectural University of Medicine

9. Children’s Hospital of Michigan Pediatrics Wayne State University

10. Shizuoka Children’s Hospital

11. Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency

12. Cook Medical Inc.

13. Medtronic Inc.

14. Medtronic Japan Co., Ltd.

15. Abbott Inc.

16. Abbott Medical Japan Co., Ltd. and Abbott Vascular Japan Co., Ltd.

17. The Joseph M. Sanzari Children’s Hospital, Hackensack University, Seton Hall Hackensack School of Medicine

Publisher

Japanese Circulation Society

Subject

Cardiology and Cardiovascular Medicine,General Medicine

Link

https://www.jstage.jst.go.jp/article/circj/84/5/84_CJ-19-1092/_pdf

Reference15 articles.

1. 1. Pharmaceuticals and Medical Devices Agency. Approved medical devices in Japan (in Japanese). https://www.pmda.go.jp/review-services/drug-reviews/review-information/devices/0018.html (accessed September 1, 2019).

2. 2. Kusuoka H, Yamane T. Discussions on evaluation of medical device in Pediatric, December 16, 2015. https://www.pmda.go.jp/files/000209947.pdf (accessed September 1, 2019).

3. 3. Ministry of Health, Labour and Welfare. Overview of orphan drug/medical device designation dystem. https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html (accessed September 1, 2019).

4. 4. Ministry of Health, Labour and Welfare. Strategy of SAKIGAKE. https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html (accessed September 1, 2019).

5. 5. Konishi A, Isobe S, Sato D. New regulatory framework for medical devices in Japan: Current regulatory considerations regarding clinical studies. J Vasc Interv Radiol 2018; 29: 657–660.

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