A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior-Reference-Cited by-同舟云学术

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A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior

Published:2020-04-03 Issue:5 Volume:13 Page:877-879
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Ota Nagomi¹,Tachibana Keisuke¹,Kusakabe Tetsuya²,Sanada Shoji²,Kondoh Masuo¹

Affiliation:

1. Graduate School of Pharmaceutical Sciences Osaka University Osaka Japan

2. Graduate School of Medicine Osaka City University Osaka Japan

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12784

Reference14 articles.

1. Summary of safety and effectiveness data of BRACAnalysis CDx. .

2. Notification of partial and minor change of medical devices. .

3. A report of the Health Sciences Council in MHLW. .

4. Draft of Japanese pharmaceutical affairs law. .

5. The Pharmaceutical and Medical Device Act Act No. 63 of 2019. .

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