title: Multiregional medical device development: regulatory perspective.
abstract: There are difficulties in conducting worldwide medical device development simultaneously because each country and/or region has their own medical device regulations. However, to aid globalization of the medical device market, and to quickly provide innovative medical devices to patients, attempts have been made to encourage harmonization and convergence of medical device regulations. 'Harmonization by doing' is a bilateral effort from the United States and Japan to develop global clinical trials and address regulatory barriers that may be impediments to timely device approval. The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. Since 2012, the GHTF has been replaced by the International Medical Device Regulators Forum.
authors.affiliation: Pharmaceuticals and Medical Devices Agency, Kansai Branch, Knowledge Capital Tower C9, Grand Front Building, 3-1 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan, tamura-atsushi@pmda.go.jp.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Tamura
authors.forename: Hiromu
authors.initials: H
authors.lastname: Kutsumi
mesh_terms: D004869:Equipment Safety; D004864:Equipment and Supplies; D006801:Humans; D038622:Internationality; D061214:Patient Safety / Q000331:legislation & jurisprudence*