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…
Author: gloizou
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…
MEDICAL DEVICES LICENSE HOLDING / SPONSORSHIP Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation……………….via contact us. Compliance Management Solutions Melbourne, Australia (Head Office) E: gloizou@compliancems.com.au M: +61 433 124 266…
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…
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://compliancems.com.au
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…
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…
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)…
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…
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…