IMDRF Stakeholders Meeting Nicole Denjoy DITTA Vice-Chair COCIR Secretary General IMDRF Open Stakeholders Forum Sydney, Australia September 26, 2012
What is DITTA? • DITTA is the Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association • DITTA is associations of manufacturers that represent medical imaging, radiation therapy, healthcare IT, electromedical and radiopharmaceutical manufacturers. • Member companies manufacture: medical x-ray equipment; computed tomography (CT) scanners; ultrasound; nuclear imaging; radiation therapy equipment; magnetic resonance imaging (MRI); imaging information systems; medical software and health IT; and radiopharmaceuticals. • DITTA was officially incorporated in 2012 as a non-profit trade association in the United States after more than 12 years of existence. • DITTA’s membership currently includes COCIR (Europe), JIRA (Japan), MEDEC (Canada), MITA (United States), THAIMED (Thailand), CAMDI (China) and IMEDA (Russia). 2
What does DITTA do? DITTA Member Goals: • Build and improve public awareness • Detect disease early and relevance of industry products in • Improve the quality of care healthcare and its benefits for patients • Reduce the likelihood of medical errors and users • Lower the long-term cost of health care • Advocate for efficient and appropriate regulation that promotes innovation DITTA Activities: • Enhance the global competitiveness of • Communicate, cooperate and member companies coordinate between associations • Identify unnecessary regulatory • Identify topics and trends with global burdens industry impact • Promote and pro-actively provide • Develop and submit joint industry solutions to harmonize regulatory positions frameworks as much as possible • Promote ethical conduct and practices (approved once, accepted everywhere) • Leverage the benefits of international • Expand market access for member standards companies • Streamline clearance processes 3 www.globalditta.org
Since the last meeting in Singapore, DITTA has… 1. Incorporated in the United States as a non-profit trade association 2. Delivered presentations to the World Health Organization (WHO) 3. Submitted letters to Dr. Kelly and prepared an IMDRF future work template on medical software 4. Been actively participating in the IMDRF RPS and UDI working groups 5. Added three new member associations and developed a formal membership structure: CAMDI, IMEDA and THAIMED 6. Worked to host an event with the World Bank that will take place in Washington, DC on 27 September on procurement of medical technology 7. AHWP agreed to host a DITTA medical software workshop during their November conference in Taipei, Taiwan 8. Attended the special session with representatives from GMTA and DITTA of the IMDRF Management Committee meeting (September 25, 2012) 9. Created four new DITTA task forces bringing experts from its constituency including one on RPS (Regulated Product Submission) and one on UDI (Unique Device Identification) www.globalditta.org
In February, we asked and you delivered… 1. The Management Committee be open to industry and other interested parties. DITTA and GMTA were invited to attend the special session of the Management Committee 2. Industry and other key stakeholders should be allowed to participate in IMDRF working groups. DITTA is actively participating in the IMDRF RPS and UDI Working Groups 3. IMDRF should commit to the legacy of GHTF by keeping its documents up-to-date. The global regulatory model should continue to be the basis for future projects. In a letter to DITTA, Dr. Kelly acknowledged the importance of GHTF 4. Industry should be recognized as an important stakeholder, and be able to make recommendations in defining the overall IMDRF strategy and work plan. In a letter to DITTA, Dr. Kelly acknowledged industry as an important stakeholder 5. The importance of international standards should be acknowledged with a strong commitment. In a letter to DITTA, Dr. Kelly acknowledged the importance of standards 4 www.globalditta.org
Thank You…. …. And there is more to do: DITTA stands ready to work with IMDRF www.globalditta.org
DITTA continues to recommend that in the short-term , IMDRF… 1. Establish a specific group to ensure GHTF documents are kept up to date . This group should include industry experts who have participated to GHTF. 2. Create a standards working group comprising all stakeholders as appropriate. 3. Accelerate the IMDRF UDI Work Team working groups activities to finish recommendations and rules in first half of 2013, and to suggest a clear timeline to understand a global adoption scheme. 4. Provide rationale when an industry proposal is rejected. www.globalditta.org
DITTA continues to recommend that in the long-term , IMDRF… 1. Develop regulatory frameworks fostering innovation and considering global trade 2. Require IMDRF regulators to implement IMDRF decisions in a reasonable timeframe. As part of this process, IMDRF members should report on implementation at IMDRF meetings. 3. IMDRF should work towards, as practical, a common data set for pre-market approval/clearance and post-market activities. 4. IMDRF to adopt a harmonized submissions format , preferably RPS (Regulated Product Submission). 5. Encourage the adoption/recognition of combined audit schemes that fulfill the requirement for each region (e.g. QSR, CMDCAS, etc.) in order to reduce the number of audits (covered by a New Item IMDRF adopted) www.globalditta.org
Conclusion 1. Only mutual trust and structural collaboration between regulators and regulated industry in developing systems will contribute to enhanced patient safety, better access to health and cost-efficient healthcare systems. 2. Collaborative partnership between regulators and regulated industry is paramount 3. DITTA is committed to strengthening its contribution with IMDRF and other stakeholders in the interest of patient safety and better patient access to advanced medical imaging, radiation therapy and health IT technologies. 4. DITTA supports the 5 items on IMDRF agenda 5. DITTA anticipates acceptance to set-up a new work team on medical software 6. DITTA will submit a NWIP to IMDRF on International standards . 10 www.globalditta.org
Thank you for allowing DITTA participation and contribution in the IMDRF process
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