International collaboration highlights

Since 2012, we have participated in the Medical Device Single Audit Program (MDSAP). This allowing recognised Auditing Organizations to audit manufacturers in a single program that satisfies the requirements of participating regulatory authorities. 

We support the UK Medicines and Healthcare products Regulatory Agency (MHRA) in its new international recognition framework for medicines. This framework builds on partnerships like the Access Consortium and Project Orbis and is tailored to the UK’s post-Brexit regulatory environment.
We joined with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to establish a Joint Committee to implement the medical device sectoral annex of the Australia - UK Mutual Recognition Agreement (MRA).

We enacted the Therapeutic Goods (International Agreement–Notice of Prohibition) Instrument 2021. This supports the Minamata Convention, a global treaty addressing the environmental and health impacts of mercury.

Launch of a global pilot programme to coordinate inspections of manufacturers producing sterile medicines.

We joined the International Medical Device Regulators Forum (IMDRF) pilot to test the Table of Contents (ToC) submission format.

We were accepted as an assessor in the EDQM Certificate of Sustainability (CEP) assessment process. The certification procedure for CEPs assesses the suitability of monographs to control the chemical purity, microbiological quality and transmissible spongiform encephalopathy (TSE) risk (if relevant) for any substance covered by a European Pharmacopoeia monograph.

Medical device amendments to the EU-Australia MRA on conformity assessments came into effect.

The Australia-United States Free Trade Agreement came into force.