If your company does not have a physical location within the country, Australian law dictates that you must appoint a "Sponsor" who is located within Australia to act as your liaison with the Therapeutic Goods Administration (TGA). Emergo is an official Sponsor representative for medical device and IVD companies with a physical office in Sydney, Australia.
Why choose Emergo as your Australian TGA Sponsor?
Emergo has been a TGA Sponsor service provider for medical device companies since 2003. We are an ISO registered regulatory consulting firm that has been in operation since 1997, concentrating solely on medical device and IVD quality assurance and regulatory issues. We maintain offices in over 25 countries worldwide, and can act as your in-country representative through our local offices in these markets as well. Read about the benefits of appointing an independent Australian TGA Sponsor instead of a distributor.
What we provide as your TGA Sponsor for Australia:
- Register your medical device(s) and IVD(s) with the TGA prior to commercialization.
- Act as your primary point of contact for the TGA.
- Ensure that your Technical File is made available for inspection by the TGA.
- Authorization to place our name and address on your device labels, packaging, Instructions for Use, etc.
- In house regulatory experts to interact between you and the TGA.
- Assistance with Vigilance: Reportable Recalls/Adverse Events reporting to the TGA, in cooperation with you and your distributors.
- Protection of your confidential documentation. The Sponsor can only show them to the TGA.
- Available to represent you to the TGA for consultation in case of withdrawal of a medical device from the market.
- Secure online access to Labeling Information & Symbols, Technical Dossier Templates, Quality System Procedures (QSPs or SOPs), Medical Device Regulations, Vigilance Guidelines, Classification Guidelines, Reportable Recalls/Adverse Events, Harmonized Standards, and more.
- Notify, or be notified by, the TGA of serious adverse device events.
Ask us about our special 3 year package for new Australia Sponsor representation clients.
Please contact us to receive more information on Australia TGA Sponsor representation exclusively for medical device and IVD companies.