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Introduction to TGA Medical Device Registration in Australia
Greenhouse and Energy Minimum Standard (GEMS). Since October 1, 2013, MEPS certification is no longer recognized, and regulated products must have GEMS certification before they can be marketed. State government legislation and regulations stipulate compliance with relevant Australian Standards as they relate to Energy Performance Standards (MEPS) and energy efficiency for electrical products such as external power supplies, refrigerators, air conditioners, washing machines and TVs.
As of March 2016 all electrical/electronic and radio equipment intended for use in Australia and New Zealand must comply with AMCA regulatory requirements and must bear an RCM marking. Created in 2013, the Regulatory Compliance Mark (RCM Mark) replaced both the C-Tick and A-Tick certification programs in Australia. By combining compliance requirements for telecoms equipment and EME/EMC testing, the RCM Mark provides a single, integrated approach to certification for wireless devices in Australia and New Zealand.
Australia SAA Approvals
Standards Association of Australian The following sets out the regulatory definitions of: The Declared Articles for REAS under the NSW Electricity (Consumer Safety) Act 2004 REAS – NSW Gazette; andThe Electrical Equipment Safety Scheme (EESS) of Level 2 and 3 in-scope-equipment as published in AS/NZS 4417.2. Refer to this standard for a full list including NZ variants.