ESS ESS AUS In-Vitro Diagnostics

Regulatory ESSENTIAL

Australia - In-Vitro Diagnostics

Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

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

Scope:	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)
Stakeholders:	Manufacturer, Importer, B2C products, B2B products
Legislation in force:	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 5 - Advertising, counterfeit therapeutic goods and product tampering 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 5 - Including medical devices in the Register Part 6 - Suspension and cancellation from the Register Part 7 - Exempting medical devices from inclusion in the Register Part 8 - Obtaining information Part 9 - Fees 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 4 - Exempt devices Schedule 5 - Fees
Application national:	Australia, IVD devices, Therapeutic Goods Act, Australian Sponsor, TGA, ARTG
Countries:	Australia,
Status:	Published 2023-05-25 by Anette Dunkel-Reinboth and Torsten Sahm Last change 2024-03-25 by Torsten Sahm: FTA/MRA status with EU, In Vitro Diagnostic (IVD)
ROGER WILLCO ID:	#jp6c
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Content of this Essential

Scope of this ESSENTIAL

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)'

Abbreviations

Here you will get textual information

Important abbreviations which are special for this legislation or theme.

Analysis of regulatory requirements

Legislation in force for this PCT

Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors

Here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)

Here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses

Here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties

Here you will get related hyperlink(s)

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU

Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

FTA/MRA status with EU

Here you will get related hyperlink(s)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

Here you will get related hyperlink(s)

Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Hints

Here you will get a image or chart

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?

Here you will get related hyperlink(s)

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?

Here you will get textual information

[Yes/No]

IMDRF Membership

Here you will get textual information

Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Equipment authorization (approval process)

Approval process (conformity assessment procedure)

Here you will get textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)

Here you will get a image or chart

Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority

Here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal

Here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?

Here you will get textual information

e .g. formal application

Is a factory inspection legally required

Here you will get textual information

Hints

Here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing

Here you will get textual information

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards

Here you will get textual information

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment

Here you will get related hyperlink(s)

Acceptance of foreign test reports

Here you will get related hyperlink(s)

Hints

Here you will get textual information

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)

Here you will get textual information

e. g. product label

Regulatory e-labelling allowed?

Here you will get related hyperlink(s)

e. g. put the regulatory information and labels in a software menu

User instructions language(s)

Here you will get textual information

Regulated by the legal provisions

User instruction requirements and specific compliance notes

Here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

General Information:

Code, Continent	AUS, Australia
Economic Area	APEC
Official Language	Australia does not have an official language, the main language of Australia is definitely ENGLISH. The written English used is closely related to the English of Britain, although there are a few differences in spelling.
Standard Institute	Standards Australia \| https://www.standards.org.au/
HS Codemember	Yes

In Vitro Diagnostic (IVD)

Australia