The implant Files a global collaboration of International Consortium of Investigative Journalists, today summarised the medical device regulation changes that have been made throughout the world since it first started reporting three months ago.

Unsurprisingly Australia is no where to be found.

Our Health Minister Greg Hunt and State Health Ministers are yet to respond or address medical device regulation.

This is why Mesh Awareness Australia has joined forces with Breast Implant Illness Australia and New Zealand and Essure Problems Australia and New Zealand in our call for a Royal Commission into Australia’s regulation of Medical Devices.

Countries that have made an effort to reform Medical Device regulation include

Canada: Planning to introduce mandatory reporting of adverse events(complications) by Canadian hospitals. .

Germany: Health Minister introduced legislation for medical device national register to track devices safety and performance.

Netherlands: Health minister is waiting for reforms that are dependent on new 2020 Europe Union regulations. It is important to note that Europe Union regulations have not changed since 1993.

India: Regulators have meet to implement device regulation that was legislated over 10 years ago.

United Kingdom: Considering a nationwide medical device registry and has drawn up plans for this.

US: Promising to introduce initiatives that have been languishing for years, initiatives like compile and analyse medical device data and improvements to its 501(k) process.

Once again we wish to thank everyone who has signed and shared our petition.

Please keep sharing. We are really hoping to reach 10,000 signatures. 

Respect and Gratitude.

Mesh Awareness Australia
Breast Implant Illness Australia and New Zealand
Essure Problems Australia and New Zealand