First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan　― Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent ―-Reference-Cited by-同舟云学术

First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan　― Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent ―

Published:2018-05-25 Issue:6 Volume:82 Page:1487-1490
ISSN:1346-9843
Container-title:Circulation Journal
language:en
Short-container-title:Circ J

Author:

Konishi Akihide¹,Ho Mami¹,Shirai Yuko¹,Shirato Haruki¹

Affiliation:

1. Office of Medical Device III, Pharmaceuticals and Medical Devices Agency

Publisher

Japanese Circulation Society

Subject

Cardiology and Cardiovascular Medicine,General Medicine

Link

https://www.jstage.jst.go.jp/article/circj/82/6/82_CJ-17-1425/_pdf

Reference15 articles.

1. 1. Ide K. Medical device regulations and utilization of international standards in Japan. Tokyo: Pharmaceuticals and Medical Devices Agency http://www.mhlw.go.jp/file/04-Houdouhappyou-11123000-Iyakushokuhinkyoku-Shinsakanrika/regulation_medicaldevices.pdf (accessed January 12, 2018).

2. 2. Pharmaceuticals and Medical Devices Agency. Differences among brand-new medical devices, improved medical devices and generic medical devices (in Japanese). Available at: https://www.pmda.go.jp/files/000155726.pdf (accessed January 12, 2018).

3. 3. Pharmaceuticals and Medical Devices Agency. Re-examination system under the old pharmaceutical affairs law (in Japanese). Available at: https://www.pmda.go.jp/review-services/reexamine-reevaluate/re-examinations/0005.html (accessed January 12, 2018).

4. 4. Pharmaceuticals and Medical Devices Agency. Use-results survey system under the pharmaceuticals and medical devices act (in Japanese). Available at: https://www.pmda.go.jp/files/000160083.pdf (accessed January 12, 2018).

5. 5. Pharmaceuticals and Medical Devices Agency. Fundamental point of view about use-results survey system (in Japanese). Available at: https://www.pmda.go.jp/files/000197726.pdf (accessed January 12, 2018).

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