As you may be aware, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or…
Before someone can supply a medical device for sale in Australia they are required to make an application to include the device/system in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation…
If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this new regulation? All cosmetic products exported to Europe will have…
Australian TGA Medical Device Sponsors Before someone can supply a medical device for sale in Australia they are required to make an application to include the device in the ARTG. The sponsor is the person or company responsible for the importation…
Internal Audits Internal audits MUST be completed for all organizations that are ISO 9001/13485/22716 certified. It is a process that a notified body will review at surveillance or re-certification. If you don’t perform internal audits in your organization the probability of striking…
Corrective and Preventive action: A continuous improvement tool that can be extremely effective if used correctly. This tool is used not only for ISO 9001 organizations but also for organizations that comply to Cosmetics GMP ISO 22716, TGA GMP Pharmaceuticals,…
Australian Medical Device Sponsorship Before someone can supply a medical device for sale in Australia they are required to make an application to include the device in the ARTG. The sponsor is the person or company responsible for the importation…
To all Australian cosmetic exporters – the new Cosmetic Regulation “Cosmetics GMP” is now in effect. This means that companies will now be required to demonstrate compliance to this new regulation. Companies can demonstrate compliance with this regulation by implementing: ISO…
What is a medical device? As per the Therapeutic Goods Regulation 2002, Section 41DB, a medical device is: 1. ‘any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its…
To all Australian cosmetic exporters – the new Cosmetic Regulation “Cosmetics GMP” is now in effect. This means that companies will now be required to demonstrate compliance to this new regulation. Companies can demonstrate compliance with this regulation by implementing: ISO…