In-Vitro Diagnostics

Under the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) in-vitro diagnostics would be controlled in a similar fashion to medical devices.  However, there is now uncertainty regarding the future of ANZTPA but it is expected that in-vitro diagnostics will eventually come under some regulatory controls in the future.  We can provide advice on the regulatory controls as they become apparent to ensure compliance for your in-vitro diagnostics.