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[…]
Category: Uncategorized
Australia TGA ARTG Medical Device Sponsorship
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[…]
MDR 2017/745
GOODBYE GMDN………………….HELLO EMDN The EMDN will be the nomenclature used when registering medical devices In the Eudamed database. Although mapped to the current GMDN Nomenclature, it is stand alone and will be used in future[…]
Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more………………………………
Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more……………………………… Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop[…]
TGA ARTG Medical Device Sponsorship
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[…]
C | M | S GONE GLOBAL
Need Australian TGA / European EU Rep or Asian Medical Device Representation? MEDICAL DEVICES LICENSE HOLDING / TGA SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check out our website[…]
Software As A Medical Device
NEW TGA Classification Rules for software The TGA has proposed new classification rules for software based medical devices, including smart phone apps. This means that classification rules are now based on risk to individual or[…]
Software As A Medical Device
NEW TGA Classification Rules for software The TGA has proposed new classification rules for software based medical devices, including smart phone apps. This means that classification rules are now based on risk to individual or[…]
C | M | S GONE GLOBAL
Need TGA / European or Asian Medical Device Representation? MEDICAL DEVICES LICENSE HOLDING / SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and[…]
TGA ARTG Medical Device Sponsorship
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[…]