Actually No,CE Mark is Not Required for Australia Medical Devices
<<<<<<No CE Mark, no exports to Australia.>>>>>> FALSE
In 10/2018 Australia expanded the list of International Assessments that it accepts for Medical Devices.
Comparable overseas regulators for medical device applications 26 July 2019
The TGA has expanded the range of international assessments and approvals from comparable overseas regulators that sponsors can choose to provide when submitting their applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG). TGA is also increasing the use of assessment reports as the basis for abridgement of the assessment of an application for a TGA conformity assessment certificate.
The Expert Review of Medicines and Medical Devices Regulation (MMDR) made recommendations aimed at streamlining the TGA's processes for including medical devices in the ARTG in order to improve access by Australian consumers to new medical devices. The Government decided that the TGA should make greater use of marketing approvals for devices in overseas markets when the device has been approved by a third party that has been designated by an authority that is similar to the TGA, or by a comparable overseas regulator (in line with MMDR Recommendation 15, Pathways 2A & 2B).
The TGA has long accepted certification from European notified bodies as evidence of compliance with the conformity assessment procedures, in addition to the conformity assessment certificates issued by the TGA.
Since October 2018, comparable overseas regulators and assessment bodies include:
Notified bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union
the Food and Drug Administration of the United States
Health Canada
Medical Device Single Audit Program (MDSAP) Auditing Organisation
the Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency of Japan.
News 
Market Data 
Discover 
