Currently, the TGA is the only Notified Body in Australia that can issue Conformity Assessments (CA). There has been significant movement with respect to CA for Australian medical device manufacturers. It is expected that in 2015[…]
ISO 22716 – New Cosmetics Global Regulation
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[…]
Australian Medical Device Registration / Sponsorship
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[…]
Australian Medical Device Distribution
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[…]
ISO 22716 – Cosmetics GMP
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[…]
Australian (TGA) Medical Device Sponsor
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[…]
ISO 9001 / ISO 13485 clause 8.2.2 | ISO 22716 Cosmetics GMP clause 16 – Internal Audit
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[…]
ISO 9001 / ISO 13485 clause 8.5.2 / 8.5.3 | ISO 22716 Cosmetics GMP clauses 13/14/16 | TGA GMP – Corrective and Preventive Action (CAPA)
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[…]
TGA (Australian) Medical Device Sponsorship
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[…]
Cosmetics GMP – ISO 22716 Eureopean Regulation EC 1223/2009
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[…]