WASHINGTON, DC – The Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) today participated in the 2nd International Medical Regulatory Forum Open Session held in Sydney.
This session was attended by almost 90 participants, including regulators, industry and notified bodies. The IMDRF Management Committee composed of regulators from Australia, Brazil, Canada, China, Europe, Japan and the US and representatives of the WHO and Asian Harmonization Working Party (AHWP) shared the progress made on the five items they approved at their first session in Singapore in February. In addition, they gave a brief update on the current regulatory framework in their jurisdiction.
This open session was an opportunity to communicate on matters of common interest. The global medical device industry is happy to see that regulators are today willing to strengthen the communications channels between themselves and take the opportunity to learn from each other in the interests of having a workable and efficient regulatory system.
Nicole Denjoy, DITTA vice-chair said, “As an industry, we are looking for a globally harmonized regulatory framework that is smart, efficient and can guarantee transparency, as well as patient safety, high quality and rapid access to highly-innovative medical technology. ‘State of the art’ standards for medical devices are essential.”
DITTA members are particularly interested in sharing their knowledge and competences towards concrete goals which have been set by IMDRF such as establishing a global Unique Device Identification (UDI) scheme and an efficient Regulated Product Submission (RPS) system. DITTA looks forward to continuing our contribution on specific items such as medical software.
Nicole Denjoy added “We have seen significant progress on the five items since Singapore and are hopeful that this will continue efficiently and translate into timely implementation.”
For more information on DITTA, visit the website www.globalditta.org.
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