Category: DITTA Press releases
San Francisco, CA – The 5th International Medical Device Regulators Forum (IMDRF) meetings took place in San Francisco on 25-27 March 2014 under the chairmanship of US Food and Drug Administration. DITTA congratulates the IMDRF Chair for having organized excellent meetings and for providing opportunities for effective interactions between regulators and stakeholders.
This was a unique opportunity to meet and receive the most updated information first-hand on how medical device regulations are evolving around the globe. Posting regulators’ updates prior to the meetings contributed to a greater level of transparency.
Updates shared on the IMDRF work items in focus among regulators showed good progress and a higher level of maturity that will enable higher convergence among the member economies fatigue when implemented. On this occasion, DITTA published key messages on three of those topics.
DITTA Contribution on Medical Device Single Audit Program
DITTA Contribution on Software as a Medical Device
DITTA contribution on Unique Device Identification (UDI)
The Stakeholder Forum had a particular value with a new format of three parallel topical sessions (Software as a Medical Device, Medical Device Single Audit Process, WHO session) allowing all the participants to share, openly discuss and dive deep in these matters as one community.
Software as a Medical Device, a DITTA proposal, was accepted in March 2013. Under the US FDA leadership, the group made tremendous progress and received a very positive feedback from the attendees.
This week, DITTA presented a new Work Item on ‘Processing of used medical systems’ to IMDRF and stressed the importance and necessity to have safe and effective equipment at global level. Gail Rodriguez, MITA Executive Director and DITTA Vice-Chair said, “Equal and affordable access to state-of-the-art healthcare technology with high quality requires a common approach from regulators and industry.”
DITTA was given also the opportunity to present on the importance of International standards. Nicole Denjoy, COCIR Secretary General and DITTA Chair expressed, “International Standards are essential elements complementing smart regulations in addressing patient safety and innovative technologies. The commitment of IMDRF remains of key importance.”
The 6th edition of IMDRF will take place in Washington, DC on 16-18 September, 2014. DITTA is committed to continuing its contribution to regulatory convergence at global level.