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[…]
TGA/Australian Medical Device Sponsors
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[…]