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ESS JPN In-Vitro Diagnostics
In vitro diagnostic; IVD devices; IVD devices; CMDE; Electronic registration; NMPA; UDI regulation; UDI Code; IMDRF; Classification Rule; ISO 15223-1 symbol; vigilance

30-Tages-Lizenz

Anwendungsbereich des Regulatory Essentials

This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostic devices in Japan, based on the - Act on Pharmaceuticals and Medical Devices" (PMD Act) - MHLW and PMDA documents/guides In-Vitro-Diagnostics are regulated under the "Pharmaceuticals and Medical Devices" Acts. The main information is provided in: Regulatory ESSENTIAL JPN Medical Devices. This ESSENTIAL lists the IVD specific information only.

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:

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Länder:

 

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Status:

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ID:

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Inhalt des Regulatory Essentials

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