Australia has a strong health care system and a complete medical management and insurance system to provide people with complete health care services. At present, all medical supplies (drugs and medical devices) listed in Australia must be registered or registered with the Australian Register of Therapeutic Goods (ARTG) in accordance with the relevant requirements before they can be legally listed, to ensure the safety and effectiveness of medical devices are guaranteed.
Supervisory bodies and regulations:
- Supervisory body: TGA is the abbreviation of Therapeutic Goods Administration, which is the supervisory body of medical goods (including drugs, medical devices, genetic technology, and blood products) in Australia.
- Regulatory requirements:
✔ Therapeutic Goods Act 1989 - the Act.
✔ Therapeutic Goods (Medical Devices) Regulations 2002-the Regulations.
- Regulatory pathway: Pre-market notification/registration.
- Authorized representative: Australian Sponsor Australian agent (Australian agent)
- QMS requirements: Medical Device Single Audit Program (MDSAP) Medical Device Single Audit Program.
In Australia, in vitro diagnostic products (IVDs) are regulated as a subset of medical device products (MDs), and their intended purpose and risk management approach is the basis for the classification of medical devices, for which manufacturers are responsible. The higher the classification level of a device, the more demanding the conformity assessment process applied to the device. If multiple classification rules apply to a particular medical device, the device is classified according to the highest risk level that applies.
Recognize the authorization documents of some overseas regulatory agencies.
1. Certificates issued by notified bodies designated by the medical device regulatory authorities of EU member states under the EU medical device regulatory framework.
2. Decisions of the U.S. Food and Drug Administration (FDA).
3. approvals and licenses issued by Health Canada HC.
4. premarket approval in Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceutical and Medical Devices Agency (PMDA), or the Registration and Certification Body (RCB), as applicable).
5. certificates and reports issued under the Medical Device Single Audit Program (MDSAP)*.
6. an ISO 13485:2016 certificate issued by a certification body that is also a designated Notified Body under IVDD 98/79/EC (only for IVD inclusion applications prior to May 26, 2022)
7. ISO 13485:2016 certificate issued by an accreditation body that is a signatory to the International Accreditation Forum (IAF MLA) Multilateral Accreditation Arrangement (only applicable to IVD inclusion applications before May 26, 2022).
TGA Certificate of (Conformity Assessment CertificatesCAC).
For system and program packages: Submit a self-conformity statement (in accordance with TGA regulations).
HTW Australia TGA Services :
Device classification and grouping services.
TGA manufacturer evidence guidance and audit.
Foreign manufacturer registration guidance.
Preparation (editing) of technical documents and instructions in accordance with TGA requirements.
Provision of Australian agency services.
Assistance with regulatory due diligence for agents.