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Regulatory ESSENTIAL
Australia - In-Vitro Diagnostics

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

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Stakeholders:      Manufacturer, Importer, B2C products, B2B products     
Application: Australia, IVD devices, Therapeutic Goods Act, Australian Sponsor, TGA, ARTG
Countries: Image for AU Australia,  
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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)
   
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:


In Vitro Diagnostic (IVD)

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 licence)

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 licence)

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 licence)

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:

   Australia

Code, ContinentAUS, Australia
Economic AreaAPEC
Official LanguageAustralia 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 InstituteStandards Australia | https://www.standards.org.au/
HS CodememberYes

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