Australian Medical Device Conformity Assessment Regulations updated by the TGA
In July 2021 the Therapeutic Goods Administration (TGA) published significant updates to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
Personal Protective Equipment (PPE) Regulation as a Medical Device by the TGA
Due to the COVID-19 pandemic, the demand for PPE has significantly increased. In response to the greater demand, the TGA has issued guidance on the regulation of face masks, gloves
Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
The TGA has changed the inclusion process by which non-measuring, non-sterile Class I medical devices are included in the ARTG. The changes came into effect October 2020.
TGA’s Medical Device Regulatory Changing Landscape
In 2020, the TGA are implementing a range of changes to the medical device regulations due to a number of reasons; some of which include changes to the European device regulations
Importance of Data Integrity and Document Management
In recent years there has been increased emphasis on data integrity, as this is a critical factor for the manufacturer in measuring the quality of their product and their credibili
Tips for transitioning to ISO 13485:2016
As the March 2019 deadline for ISO 13485:2016 is fast approaching, now is the time to start actively planning for the transition. When planning for the transition, it is important
The New EU MD Regulations on Notified Bodies. Will They Affect Australian Manufacturers?
In September 2012, the European Commission announced a proposal for regulation changes to medical devices and in vitro diagnostic medical devices. According to Medtech Insight News
Red light on ANZTPA
The establishment a joint therapeutic products regulator between Australia and New Zealand will no longer continue.
European Union Commission Release New Vigilance Guidance
The EU Commission have released revision 8 of MEDDEV 2.12-1: Guidelines on a Medical Device Vigilance System. The updated version includes guidelines for In Vitro Fertilisation (IV
Electronic Age: UK MHRA Issue Guidance On eIFU Requirements
The EU regulation on electronic Instructions for Use (IFU) (Regulation 207/2012) came into force on March 1st 2013. In response to the implementation of electronic IFUs, the UK Med
