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ESS AUS 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 Australia, based on the - Therapeutic Goods (Medical Devices) Regulations 2002 - Information provided by the Therapeutic Goods Administration (TGA) IVD products are classified into four risk classes, according to the risk associated with their use. Class 1 - No public health risk or low personal risk Class 2 - Low public health risk or moderate personal risk Class 3 - Moderate public health risk or high personal risk Class 4 - High public health risk Not in scope of this CRF: - Medical Devices (see: ESSENTIAL AUS Medical Devices)

Stakeholder:

Manufacturer, Importer, B2C products, B2B products

Geltende Rechtsvorschriften:

Content: Chapter 1 - Preliminary Chapter 2 - Australian Register of Therapeutic Goods Chapter 2A - Prohibition on import, export, manufacture or supply of therapeutic goods—international agreements Chapter 3 - Medicines and other therapeutic goods that are not medical devices Chapter 4 - Medical devices Chapter 4A - Vaping Goods Chapter 5 - Advertising, counterfeit therapeutic goods and product tampering Chapter 5A - Enforcement Chapter 6 - Administration Chapter 7 - Miscellaneous Chapter 8 - Repeal and transitional provisions A medical device is defined as: any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings. (Section 41BD) Content: Part 1 - Preliminary Part 2 - Essential principles Part 3 - Conformity assessment procedures Division 3.2 - Conformity assessment procedures 3.6A - Class 4 IVD medical devices (other than medical devices to be used for a special purpose) 3.6B - Class 4 in-house IVD medical devices (other than medical devices to be used for a special purpose) 3.7A - Class 3 IVD medical devices (other than devices to be used for a special purpose) 3.7B - Class 3 in-house IVD medical devices 3.8A - Class 2 IVD medical devices (other than devices to be used for a special purpose) 3.8B - Class 2 in-house IVD medical devices 3.9A - Class 1 IVD medical devices (other than devices to be used for a special purpose) 3.9B - Class 1 in-house IVD medical devices Part 4 - Conformity assessment certificates Part 4A - Australian conformity assessment bodies Part 5 - Including medical devices in the Register Part 6 - Suspension and cancellation from the Register Part 6A - Disposal of unused emergency medical devices Part 7 - Exempting medical devices from inclusion in the Register Part 8 - Obtaining information Part 8A - Waiver and refund of charges Part 9 - Fees Part 9A - Australian Unique Device Identification Database Part 10 - Miscellaneous Part 11 - Transitional provisions Schedule 1 - Essential principles Schedule 2 - Classification rules for medical devices other than IVD medical devices Schedule 2A - Classification rules for IVD medical devices Schedule 3 - Conformity assessment procedures Schedule 3, Part 6A - Procedures applying to Class 1, 2 and 3 in-house IVD medical devices Schedule 3, Part 6B - Procedures applying to Class 4 in-house IVD medical devices Schedule 3AA - Requirements for Australian conformity assessment bodies Schedule 3A - Disposal of unused emergency medical devices Schedule 4 - Exempt devices Schedule 5 - Fees

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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