To supply a Medical Device or IVD device in Australia, you need to include the device on the Australian Register of Therapeutic Goods (ARTG) regulated by the Australian Therapeutic Goods Administration (TGA).
If your medical device already has European CE Marking then the TGA process may be easier as the TGA recognizes the European process of CE Marking. There are however certain products that will be subject to a TGA mandatory audit.
To help you register your medical device or IVD device with the TGA and start supplying onto the Australian market we can:
Determine the Australian TGA registration requirements for your device(s).
Assist with finding the appropriate GMDN codes for your medical device(s).
Review your medical device Technical File to ensure compliance to TGA requirements.
Help prepare or review of clinical summary for your medical device as required by the TGA.
Submit application and any required documents to the TGA with continued follow up as required.
Review compliance of your medical device with all regulatory requirements (prerequisite for TGA approval).
Acrapack is proud to be a member of the following association
Regulatory Affairs and ISO 13485 expert
“Anne is prompt and efficient in all aspects of the work that she carries out for our medical company in regards to our regulatory requirements with the TGA. She demonstrates an in depth knowledge of the processes and requirements. We look forward to continuing our solid relationship.” August 20, 2014
Top qualities: Expert, Good Value, On Time Robert Yee
ACRA regulatory services as your Medical Device sponsor in Australia or New Zealand or in both countries
Acting on your behalf to register your medical device by communicating with either the Therapeutic Goods Administration (TGA) or Medsafe in New Zealand or both and carrying out obligations placed on the sponsor in relation to medical device or IVD device registrations, in order to meet and show compliance with the regulatory requirements in both countries.