The Therapeutic Goods Administration (TGA) is the competent authority for medical devices in Australia. Medical devices are divided into five classes; class I, IIa, IIb, III and Active Implantable Medical devices (AIMD). In vitro-diagnostic devices (IVDs) are divided into four different classes; class I, II, III and IV. The sponsor is responsible for registering the medical device, and all activities concerning medical devices while manufacturers have obligations to fulfill the requirements. Our country specific (*) regulatory services in Australia include:

Medical Device Specific regulation strategy reports in Australia, Medical Device Registration with the TGA, Australia Sponsor Representation for Medical Device manufacturers and TGA Technical documents Preparation and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™ 

Please fill the following form, submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Australia! 

(*) Australian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.