Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices
International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The
Considerations when outsourcing manufacture of medical devices
In the modern era of manufacturing its common for a company to make the decision to outsource part or full manufacturing of medical devices to a sub-contract manufacturer/critical
Regulatory Requirements: The Basic Information for Australian Medical Device Manufacturers
To manufacture and sell a medical device in Australia, you must hold certification from the Therapeutic Goods Administration (TGA). Depending on the risk level of the device you ma
Changes Afoot for Medical Device Manufacturers in Argentina, Brazil, Colombia and Cuba
The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers
The Australian Government Release a Blueprint for TGA’s Future – How Does This Affect Your Organisation?
The Australian government released the Blueprint for TGA’s future in early December 2011 which describes the results of 18 months of discussion and review of proposed reforms. Th
IEC 60601-1, 3rd Edition
IEC 60601-1 third edition has become a common subject of discussion for medical device manufacturers in recent times. The third edition of 60601-1 represents an overhaul of the 606
What is the ACMD and why should I be interested?
The ACMD stands for the Advisory Committee on Medical Devices, a committee which provides independent medical and scientific advice to the Minister and the Therapeutic Goods Admini
Premarket Evaluation of High Risk Medical Devices in the EU
Recently the EU has come under heavy scrutiny for failing to produce adequate premarket clinical evidence that demonstrates efficacy and safety of innovative, higher – risk medic
Some IVDs and Radiology devices to be exempt from FDA 510(k)
The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devic
