Industry News

AHWP-DITTA Joint Session on Software as a Medical Device (SaMD)

DITTA and the Asian Harmonization Working Party (AHWP) have organised a Joint Session on Software as a Medical Device (SaMD) on the 4 Nov. 2015 – 14:00 – 18:00.

For more information, please contact DITTA or AHWP.


JIRA Commences 2-Year Chairmanship of DITTA

BRUSSELS, BELGIUM – DITTA, the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association, is delighted to announce that JIRA, the Japan Medical Imaging and Radiological Systems Industries Association, has commenced the 2-year tenure of Chairmanship for 2015 and 2016.
JIRA continues on leadership efforts from COCIR, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, as Nicole Denjoy, COCIR Secretary General, chaired DITTA in 2013 and 2014. Nicole remains in the leadership as DITTA Vice Chair and also Gail Rodriguez, Executive Director of MITA, the Medical Imaging & Technology Alliance, remains DITTA Vice Chair
Satoshi Kimura, JIRA Executive Director and new DITTA Chair, said, “We are grateful to COCIR for their 2-year Chairmanship and proud of DITTA great achievements during that time and are ready to continue our contribution especially during the forthcoming IMDRF which will take place in Tokyo on 24-26 March 2015. This is an excellent timing as IMDRF chair also moved this year from US FDA to MHLW, PMDA”.
In the past two years, DITTA launched a new branding and a publication on Refurbishment of medical devices; welcomed ITAC within its Membership; held Seminars on International Standards in Medical Device Regulations, and on Single Audit Programme; contributed to the IMDRF Stakeholder Forum since the beginning, the Second WHO Global Forum on Medical Devices, and the China International Medical Device Regulatory Forum (CIMDR) in 2014 for the 2nd time and was recently granted NGO status with World Health Organisation.
Nicole Denjoy and Gail Rodriguez, DITTA Vice-Chairs, said, “We are looking forward to continue the efforts under the leadership of JIRA and all other DITTA members”. Nicole added “In particular, we will continue to bring a global industry voice to IMDRF, share our competencies on standardisation and look forward to intensifying our cooperation with WHO”.
The 7th edition of IMDRF will take place in Tokyo, Japan on 24-26 March 2015.  DITTA is committed to continuing its contribution to regulatory convergence at global level and will be well represented there.

DITTA Publication – Refurbishment of medical devices

Refurbishment of medical devices – Contribution to Circular Economy

PDF available here.

Interactive PDF available here.

DITTA Contribution to IMDRF Stakeholder Forum on open work items

The DITTA Contribution  to IMDRF Stakeholder Forum on open work items can be found here.

DITTA Holds 1st Global Seminar on International Standards in Medical Device Regulations

WASHINGTON, DC – On September 15, DITTA, the global voice of the medical imaging and radiation therapy industry, organized a day-long seminar to discuss the standards “lifecycle” from idea to implementation, including best practices, the future of international standards, and their impact on patient safety and innovation. This seminar was day 1 of the 6th IMDRF week.

Over 100 attendees from around the world came to learn from the speakers from the USA, Canada, the EU, Latin America, and Asia. Industry, Standardization Organisations, governments, healthcare professionals and other important stakeholders provided their perspectives on how standards affect their work every day. They shared best practices and openly discussed ways to increase patient safety while making smart use of regulatory resources through careful reliance on consensus-driven and science-based international standards.

MITA Executive Director and Co-Chair of DITTA Gail Rodriguez, characterized the day as “a great platform for discussion of how standards are used in regulations around the world, and how industry, regulators, and healthcare community including patients all benefit from using standards in medical device regulations. Participants agreed there is a need for more discussion on the applications for standards in medical device regulations, and identifying standards which when used effectively can contribute to safety of the equipment, enhancing quality and driving cost efficiency”.

COCIR Secretary General and Chair of DITTA Nicole Denjoy thanked the speakers and praised the outcomes of the day, saying “DITTA is very pleased with the caliber of speakers and presentations and turnout of attendees. It remains important to get support of regulators to drive regulatory convergence with the help of international standards. National deviations should be avoided to optimally benefit from international standards. This way we can also prevent from creating trade barriers.”

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