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[…]
Author: gloizou
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[…]
Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more…………………………………….
Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more……………………………………. Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a[…]
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[…]
MDR 2017/745 GOODBYE MDD………………….. WELCOME BACK MDD
GOODBYE MDD………………….. welcome back MDD……… With the commission proposing a postponement to the MDR until may 2021, it now may be possible to submit MEDICAL DEVICE CONFORMITY ASSESSMENT applications again under the mdd. Which[…]
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[…]
Cosmetics GMP for Export Purposes (ISO 22716) – Responsible Person
Cosmetics GMP for Export Purposes (ISO 22716) – Responsible Person C | M | S can now act as your European responsible Person. If you are a cosmetics exporter, you may have had been notified[…]
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[…]
Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more…………………………………….
Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more……………………………………. Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a[…]