Medical Device Regulation (MDR) European Union (EU) 2017/745 Transition – What is required by the May 2020 deadline?
Some manufacturers who have existing medical device MDD certificates may not transition before May 2020 and retain their current MDR until expiry, however a significant change to t
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
The CE Mark matters in Medical Markets
Selling any product into the European market can be simplified if a manufacturer can show that it complies with appropriate regulations. For medical device manufacturers, this comp
TGA Annual Invoicing Time – Avoid ARTG Cancellations
If you are a medical device sponsor, you would have received or you are about to receive the TGA annual charge invoice. It is important to ensure all your details are up to date wi
IVD Regulatory Compliance Deadline
Time is up for the manufacturers and sponsors of IVD devices in Australia. July 1st 2015 is the deadline for the transitional period to ensure compliance with the new regulatory fr
TGA Joint Replacements Refunds on Related Ancillary Devices
If you are a medical device sponsor, you would have received or you are about to receive the TGA annual charge invoice. It is important to ensure all your details are up to date wi
New TGA Business Site
In an effort to improve the current customer experience with the TGA ebs site, the TGA has developed a new customer friendly portal that promises to improve the on-line experience
Red light on ANZTPA
The establishment a joint therapeutic products regulator between Australia and New Zealand will no longer continue.
