• gloizou
• Feb, 25, 2016
• Uncategorized
• Comments Off on Australian TGA Medical Device Sponsor

As per the Australian TGA Medical Device Regulations, 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 company responsible for the importation of therapeutic goods into Australia. If you […]

• gloizou
• Feb, 25, 2016
• Uncategorized
• Comments Off on Cosmetics GMP for Export Purposes (ISO 22716)

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/Asia/NZ will have to be produced according to Good Manufacturing Practices. Cosmetics Good Manufacturing Practices (GMP) is one […]

• gloizou
• Feb, 25, 2016
• Uncategorized
• Comments Off on Australian TGA Medical Device Sponsor

As per the Australian TGA Medical Device Regulations, 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 company responsible for the importation of therapeutic goods into Australia. If you […]

• gloizou
• Feb, 25, 2016
• Uncategorized
• Comments Off on ISO 9001:2015 Quality Management System

The International Organization for Standardization (ISO) has just published a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision includes a number of important changes for organizations currently holding ISO 9001 certification, as well as those contemplating the development and implementation of a quality […]

• gloizou
• Feb, 25, 2016
• Uncategorized
• Comments Off on Cosmetics GMP for Export Purposes (ISO 22716)

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/Asia/NZ will have to be produced according to Good Manufacturing Practices. Cosmetics Good Manufacturing Practices (GMP) is one […]

• gloizou
• Mar, 04, 2015
• Uncategorized
• Comments Off on TGA Australian Medical Device Sponsor

As per the Australian TGA Medical Device Regulations, 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 company responsible for the importation of therapeutic goods into Australia. If you […]

• gloizou
• Mar, 04, 2015
• Uncategorized
• Comments Off on ISO 9001 : 2015

The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 […]

• gloizou
• Mar, 04, 2015
• Uncategorized
• Comments Off on Australian TGA Medical Device Conformity Assessment

As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). Finally, there has been a paradigm shift whereby the TGA will now accept conformity assessments from 3rd party Notified Bodies – what the Australian medical device industry has […]

• gloizou
• Mar, 04, 2015
• Uncategorized
• Comments Off on Cosmetics GMP ISO 22716

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 to be produced according to Good Manufacturing Practices (also includes Asian/US/NZ markets) Cosmetics Good Manufacturing […]

• gloizou
• Mar, 04, 2015
• Uncategorized
• Comments Off on Cosmetics GMP 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 exported to Europe will have to be produced according to Good Manufacturing Practices (also includes Asian/US/NZ markets) Cosmetics Good […]