• gloizou
• Jun, 11, 2017
• Uncategorized
• Comments Off on TGA Australian Medical Device Sponsorship / License Holding

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
• Jun, 11, 2017
• 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 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 of the […]

• gloizou
• Jun, 11, 2017
• Uncategorized
• Comments Off on MDSAP – Medical Device Single Audit Program

Medical Device Single Audit Program (MDSAP) – TGA Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single […]

• gloizou
• Apr, 23, 2017
• Uncategorized
• Comments Off on TGA Medical Device Australian Sponsorship for 2017-2018 Due Soon!

It’s that time of year again for companies to review their Medical Device Sponsorship costs. Before you roll over for another year with your existing Sponsor, get a quote from us! We have saved our clients thousands, let us see how much we can save you too! Speak to one of our leading specialists today […]

• gloizou
• Apr, 23, 2017
• Uncategorized
• Comments Off on New European Medical Device Regulations (MDR)

The Council of the European Union will be publishing the new 2017 Medical Device Regulations (MDR).   A summary of the major changes are illustrated below. For further information please contact Compliance Management Solutions on: E: gloizou@compliancems.com.au M: +61 4 3312 4266 W: compliancems.com.au    

• gloizou
• Apr, 23, 2017
• Uncategorized
• Comments Off on Need a TGA Australian Medical Device Sponsor / License Holder?

MEDICAL DEVICES LICENSE HOLDING / SPONSORSHIP Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation.   Compliance Management Solutions Melbourne, Australia E: gloizou@compliancems.com.au M: +61 433 124 266 W: http://s4n.223.myftpupload.com

• gloizou
• Apr, 23, 2017
• Uncategorized
• Comments Off on TGA Australian Medical Device Sponsorship / License Holding

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
• Apr, 23, 2017
• 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 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 of the […]

• gloizou
• Apr, 23, 2017
• Uncategorized
• Comments Off on Medical Device Single Audit Program (MDSAP) – TGA

Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable […]

• gloizou
• Mar, 27, 2017
• Uncategorized
• Comments Off on Need a TGA Australian Medical Device Sponsor / License Holder?

MEDICAL DEVICES LICENSE HOLDING Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information.   Compliance Management Solutions Melbourne, Australia E: gloizou@compliancems.com.au M: +61 433 124 266 W: http://s4n.223.myftpupload.com