Stakeholder:

Manufacturer, Importer

Geltende Rechtsvorschriften:

Short name: Act on Pharmaceuticals and Medical Devices" (PMD Act) Content (Excerpt): Chapter V Marketing and Manufacturing Businesses for Medical Devices and In-vitro Diagnostics Section 1 Marketing and Manufacturing of Medical Devices and In-vitro Diagnostics (Articles 23-2 to 23-2-22) Section 2 Registered Certification Bodies (Articles 23-2-23 to 23-19) Chapter IX Handling of Pharmaceuticals, etc. Section 5 Handling of Medical Devices(Articles 63 to 65) Chapter XIII Supervision Article 69 - On-Site Inspections Chapter XVII Penalties (Articles 83-6 to 91) IVD Definition (Article 2) (14) The term "in-vitro diagnostic" as used in this Act refers to pharmaceuticals intended exclusively for use in the diagnosis of diseases, which are not directly used in the bodies of humans or animals.

Nationale Anwendungsebene:

Japan, IVD Products, Act on Pharmaceuticals and Medical Devices (PMD Act), MHLW, PMDA, Marketing Authorization Holder (MAH)

Länder:

Japan

Status:

Published 2023-09-18 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2023-09-18 by Michael Loerzer: Legislation in force for this PCT, In Vitro Diagnostic (IVD)

ID:

#dy65

Code, Kontinent, Wirtschaftsraum

JPN, Asia

Wirtschaftsraum

APEC

Offizielle Amtssprache

The official language is Japanese.

Normen Institut

JSA - Japanese Standards Association | https://www.jsa.or.jp/en/

HS Codemitglied

Yes - since 1964