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[…]
Tag: Australia
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[…]
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[…]
C | M | S GONE GLOBAL
Need Australian TGA / European EU Rep / UK RP or Asian Medical Device Representation? MEDICAL DEVICES LICENSE HOLDING / TGA SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check[…]
Software as Medical Device (TGA)
The TGA transition period for software-based medical devices that met the regulatory changes set on 25 February 2021 ends on 1st November 2024. You will have until 1st November 2024 to apply for a conformity[…]
Is your product Borderline or Boundary?
Under the MDR 2017/745, medical devices are classified into different classes based on their intended use and potential risks to patients. The MDR also includes additional requirements for certain devices, including borderline products.Borderline products are[…]
FDA Breakthrough Device Program
The FDA Breakthrough Devices Program speeds up medical device development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
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[…]
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[…]