What is it? This is a system by which medical devices are identified through their distribution and use. UDI information must be placed on the label and/or package of the...
MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulatory agencies: • Therapeutics goods Administration...
Risk management is a key component to demonstrate regulatory compliance for medical devices, it contributes to the medical device company’s ability to meet the regulatory requirements for approval from local...
Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of...
The International Medical Device Regulators Forum (IMDRF) was created in February 2011 as a forum of medical device regulators from different regions around the world with the aim to build...
The EU new Medical Device Regulation (MDR) could be ready for adoption as early as by the end of 2015. Although it is more realistic to think the new regulations...
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...
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...
After the reclassification of hip, knee and shoulder joint replacement from Class IIb to Class III medical devices on 1 July 2012, there was a 3 year transition to complete...
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...