Australia Sponsor Representation for Medical Device Companies
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 Asia Pacific Pty. Ltd. is an official Sponsor for Australia with physical offices located in Sydney, Australia.
Why choose Emergo Asia Pacific Pty. Ltd. as your Australian Sponsor?
Emergo Asia Pacific Pty. Ltd. is an experienced TGA Sponsor service provider for medical device companies. We are an ISO registered regulatory consulting firm in business since 1997 and we concentrate 100% on medical device and IVD quality assurance and regulatory issues. Emergo also specializes in European, US, Canadian, Chinese and Japanese regulatory affairs so we can act as your in-country representative through our offices in these markets as well. Read about the benefits of appointing an independent Australia TGA Sponsor instead of a distributor.
What we provide as your TGA Sponsor for Australia:
- Register your medical device(s) with the TGA before they are marketed.
- Act as your primary contact point for the TGA.
- Maintain a current copy of your Technical File available for inspection by the TGA.
- Authorization to place our name and address on your device labels, packaging, Instructions for Use, etc.
- Always available to interact between you and the TGA.
- Responsible for incident reporting to the TGA, in cooperation with you and your distributors.
- Protect the confidentiality of your 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.
- Maintain reports concerning the critical evaluation of all data collected during clinical evaluations for review by TGA.
- 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/Incidents, Harmonized Standards, and more.
- Notify, or be notified by, the TGA of serious device incidents.
Please contact us to receive more information or a free proposal on Australia Sponsor representation.
