Medical Safety – New Standards Published
The following standards have now been published:-
- AS/NZS IEC 60601.2.2
- AS/NZS IEC 60601.2.45:2015
- AS/NZS IEC 60601.2.27
15
Feb
15
Feb
ACMA Compliance and Labelling from 1 March 2016 – Supplier Update
Single compliance mark—end of transition period approaching!
The single Regulatory Compliance Mark (RCM) was introduced on 1 March 2013 with a three-year transition period to 29 February 2016.
Suppliers must register on the online national database and start using the RCM by 1 March 2016.
12
Feb
The ACMA requires the supplier to sign a Declaration of Conformity (DoC) before labelling the product with the RCM
The final step to product compliance involves labelling the product:
Steps to compliance
1. Identify the applicable labelling notice
2. Identify the applicable technical standards (prescribed in the relevant labelling notice) and the testing requirements
3. Demonstrate product compliance
4. Complete a Declaration of Conformity (DoC) and maintain compliance records
5. Register as a ‘responsible supplier’
6. Label the product
The ACMA regulatory arrangements require a supplier to apply a compliance label to a product before the product is supplied to the Australian market.