Synthetic Greenhouse Gases
The Ozone Protection and Synthetic Gas (Trial Destruction Facilities and other Measures) Regulations 2013 amends the Ozone Protection and Synthetic Greenhouse Gas Management Regulations 1995 to allow trials of destruction facilities, exempt importers or manufactures of medical devices, veterinary devices, medicines and veterinary medicines that contain synthethic greenhouse gases (SGGs) from licence and levy requirements of the Ozone Protection and Synthetic Greenhouse Gas Management Act 1989 (the Ozone Act) and exempt importers or manufactures of SGGs where the whole amount of SGGs is used in medical devices, veterinary devices, medicines and veterinary medicines that contain synthethic greenhouse gases from the licence and levy requirements of the Ozone Act. The Regulation and Explanatory Statement can be viewed here.
European Union’s Waste Electrical and Electronic Equipment Directive
A revision of the European Union’s (EU) Waste Electrical and Electronic Equipment (WEEE) directive took effect on 13 Aug 2012, setting recovery and recycling targets as well as new shipping requirements for manufacturers selling non-implantable, electronic medical devices in the region.
The new law requires EU member states to recover 70% and recycle 50% of all medical device electrical and electronic equipment sold in their state. The rates will then increase to 75% and 55%, respectively, by 15 August 2015.
The directive does not apply to [ref sect 4 (g)] medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices.
While the directive is not expected to have a direct impact on Australian companies, it may be worth noting for planning purposes if Australia follows a similar trend in future.