Chapter 1 Australian TG

1. Australian Medical Device Administratio

TGA (Therapeutic Goods Administration) is the authority of Medical Device in Australia. It is the supervisory body for therapeutic goods in Australia, including drugs, medical devices, genetic technologies and blood products, specifically responsible for the import, export, production, supply and promotion of medical and sanitary products.

2. Administrative Regulation
Therapeutic Goods Act 1989
Therapeutic Goods (Medical Devices) Regulations 2002

3. Risk Classification

4. Registration Basis
Medical Device and IVD products both require manufacturer evidence to submit the registration of TG, the admissible manufacturer evidence currently are:
① Conformity Assessment Certificate AU CAB/ COC issued in Australia

② MDSAP Certificate| ISO 13485 Certificate

③ The registration approvals currently admitted by TGA are:
• AU CAB certificate.
• TGA Conformity Assessment Certificate
• EC certificate
• Health Canada Licence
• Japan Pre market Certification/ Approval
• Singapore HSA certificate
• MRA Certificate
• US FDA 510(k) Determination
• US FDA De Novo Order
• US FDA Premarket Approval

5. Registration Language
English.

6. Australian Sponsor

Australian Medical Device Sponsor is responsible for applying to the TGA for inclusion of their therapeutic goods in the Australian Register of Therapeutic Goods;

In Australia, therapeutic goods must be listed in ARTG before being sold;

Sponsor must be Australian resident or an organization incorporated in Australia and carrying on business in Australia, as well the company representative resides in Australia.

To support the post-market surveillance of TGA, once the Medical Device is listed into ARTG, the agent of Medical Device has ongoing responsibility. The statutory responsibilities include: the agent must report to TGA

Adverse event.

Overseas regulatory action.

The manufacturer conducts the results of the investigation, such as further clinical studies and review of adverse events.

The agent must also obtain the requested information from the manufactu

Chapter 2 Registration Flow | Official Fee

2. Official Fee

3. Packaging | Labelling Requirements

Chapter 3 FAQ

Q: How long does the registration of medical device in TGA?
A: The time of registration of medical device in TGA is related to many factors, product risk level、registration path、product technical documentation level、feedback speed of Sponsor and the workload of TGA officials and so on will jointly determine the registration cycle of the product.
① Registration of non-sterile/non-measured/non-reusable Class I products is expected to be approved within 1 month of submission of product documentation.
② Is/Im/Ir/IIa/IIb products can be approved within two months after submission, based on the approval of recognized country registration. If there is no approval of recognized country registration, it is necessary to initiate an application for review to TGA or a TGA accredited review body. In this way, it is necessary to consider whether the product has completed all tests as required, whether clinical tests have been completed or certificates have been obtained to assess the registration cycle.
③ In addition, even if the registration has been approved by a recognized country, the application may be fully reviewed by TGA, and if TGA issues a notice requesting a full review, the review cycle may vary from several months to one year depending on TGA's approval decision.
④ Class 3 medical devices and Class 4 in vitro diagnostic reagents have the longest registration application cycle, and TGA will conduct a comprehensive review of the product, and only through a comprehensive review of the product will be approved and obtained ARTG certificate.

Q: Does it need a QMS certificate for TGA registration of medical devices?
A: If the medical device has a recognized country registration approval certificate or proof in the TGA registration, it does not need to issue a separate QMS certificate, TGA recognizes the ISO 13485 certificate and MDSAP certificate issued by a specific body, and if the TGA requires the manufacturer to supplement the QMS evidence during the audit process, the manufacturer also needs to meet the requirements of TGA.

Q: After the registration of a medical device, can we change the Sponsor if we find that the Sponsor does not cooperate with the business?
A: Yes, TGA allows manufacturers to change Sponsors with the consent of the current Sponsor, and Wiselink AU can assist with the change.

Q: Can a product be registered by multiple sponsors at the same time?
A: Yes, but Wiselink does not recommend doing so. The manufacturer can select an independent third-party Sponsor to hold the ARTG certificate. The independent third-party Sponsor will not interfere with the manufacturer's sales business, and will actively cooperate with the manufacturer's goods import. Medical device products can be distributed to multiple dealers at the same time.

Q: Can medical device products make a registration change after the completion of registration?
A: If the change content of the medical device product meets the scope allowed by TGA, Sponsor can submit the change application to TGA, and the product can be put into the Australian market after being approved by TGA.

Chapter 4 TGA Certificate template