Top

Published in:

01-09-2013 | Letter to the Editor

Overview of medical device regulation in Japan as it relates to orthopedic devices

Authors: Umio Yamaguchi, Hirokazu Chuman

Published in: Journal of Orthopaedic Science | Issue 5/2013

Excerpt

Pharmaceuticals and medical devices (PMDs) are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) under a system that grants marketing approval only when it is indicated that effectiveness and safety are guaranteed [1]. …

Outline of PMDA. www.pmda.go.jp/english/about/history.html. Accessed 18 Oct 2012.

http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.docx. Accessed 23 May 2013.

http://www.pmda.go.jp/operations/shonin/info/new.html. Accessed 18 Oct 2012.

http://www.pmda.go.jp/operations/shonin/info/attestation/ninsyokikan.html (in Japanese). Accessed 18 Oct 2012.

http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/index_en.htm. Accessed 18 Oct 2012.

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm. Accessed 18 Oct 2012.

http://www.pmda.go.jp/english/about/midterm.html. Accessed 18 Oct 2012.

Fujiwara Y. MD reviewers’ role in the new anticancer drug approval process in the newly established Japanese regulatory agency, PMDEC (Pharmaceuticals and Medical Devices Evaluation Center). Jpn J Clin Oncol. 1998;28:653–6.PubMedCrossRef

Title: Overview of medical device regulation in Japan as it relates to orthopedic devices
Authors: Umio Yamaguchi
Hirokazu Chuman
Publication date: 01-09-2013
Publisher: Springer Japan
Published in: Journal of Orthopaedic Science / Issue 5/2013
Print ISSN: 0949-2658
Electronic ISSN: 1436-2023
DOI: https://doi.org/10.1007/s00776-013-0418-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Overview of medical device regulation in Japan as it relates to orthopedic devices

Excerpt

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Excerpt

Please log in to get access to this content

Other articles of this Issue 5/2013

Fascia iliaca compartment block: its efficacy in pain control for patients with proximal femoral fracture

Biomechanical strain characteristics of soft tissue biceps tenodesis and bony tenodesis

Hormonal therapy with external radiation therapy for metastatic spinal cord compression from newly diagnosed prostate cancer

Intra-articular distal radius fractures involving the distal radioulnar joint (DRUJ): three dimensional computed tomography-based classification

The Pavlik harness in the treatment of developmentally dislocated hips: results of Japanese multicenter studies in 1994 and 2008

Improvement of atelectasis after corrective fusion for lordoscoliosis with intrathoracic vertebral protrusion in arthrogryposis multiplex congenita: efficacy of positive-pressure ventilation test