WHO meeting with the Medical Technology Industry World Health Organization 7 May 2012 Geneva, Switzerland DITTA Overview and Contribution Nicole Denjoy, DITTA Vice Chair Olivier Denève, DITTA Representative

Since our last meeting… DITTA established a presence on the web globalditta.org including a new logo and acronym DITTA and its members (currently: COCIR, JIRA, MEDEC and MITA) have the experience and expertise to advocate to all stakeholders and to share our competencies on behalf of the diagnostic imaging, radiation therapy, healthcare IT, electromedical and radiopharmaceutical industry DITTA members are working together more effectively than ever, and we look forward to becoming more engaged on concrete matters of interest with WHO and other international policymakers, professional associations and organizations 2

Our Focus Our main focus: to improve quality, safety and patient access To promote “approved once, registered everywhere” with a harmonized global regulatory environment to ensure industry remains at the forefront of technological innovation, and continues to supply health care providers with innovative products in a sustainable, cost efficient system To achieve global harmonized regulatory frameworks: the use of international standards remain a key element as well as to facilitate trade and reduce cost of medical equipment through common, agreed and harmonized procedures To stimulate associations in emerging countries to join DITTA 3

Objectives Communicate, cooperate and coordinate between associations to: 1.Improve quality, safety and patient access around the globe 2.Develop and advocate for industry positions with global industry impact 3.Promote ethical conduct and practices 4.Advocate for least burdensome policies and regulations that promote innovation 5.Harmonize regulatory frameworks and product approval processes 6.Leverage the benefits of international standards 7.Enhance market access and global competitiveness of the industry 8.Improve awareness and relevance of industry products in healthcare 4

We... Represent the global industry in these domains 5 In-vivo diagnosis, therapy and ICT:For the following benefits: Ultrasound Medical X-ray Computed tomography (CT) Nuclear imaging Positron emission tomography (PET) Radiation therapy Magnetic resonance imaging (MRI) Imaging information Medical software, Health ICT Radiopharmaceuticals Leads to prevention and early detection of disease Improves the quality of care Supports eHealth Records Reduces the likelihood of medical errors Lowers long-term cost of health care

Update of Recent Activity DITTA website Support of IMDRF – Transition of GHTF achievements – Foster broader collaboration of regulators, industry, and stakeholders – Contribute to IMDRF work item ‘Roadmap for implementation of a UDI system’ and work item ‘Regulated Product Submission’ – DITTA proposed to IMDRF a new work item on ‘Medical Software’ Provide expertise and experience – Medical Software workshops for regulators, industry, and users – IEC rd edition workshop for Asian target groups – CCPIE conferences in China – DITTA association radiation protection efforts (IAEA, HERCA) – Member company enhanced collaboration efforts with AHWP 6

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Open Letter to IMDRF Chair (Dec. 2011) Maintain value added of work/guidance done by GHTF during the past 20 years Work closely with AHWP Accelerate global harmonization of medical device regulation Promote and use efficiently international standards Maintain and strengthen Standards Rapporteur position Industry should have a key contributing role in IMDRF activities DITTA ready to work with IMDRF to achieve mutually desired objectives of promoting globally highest level of health and safety while continuing to innovate 8

IMDRF Stakeholders Meeting Presentation (Feb. 2012) Governance – IMDRF Management Committee should be open to industry – Commit to GHTF legacy – Promote greater transparency in their efforts Membership – Expand membership beyond five founding members – New members should commit to implement IMDRF decisions – IMDRF should clarify their relationship and work with relevant bodies, ex. AHWP, IEC, ISO and WHO – IMDRF should be geographically balanced to ensure that everyone is heard Activities – Work toward “Registered once, approved everywhere” – Make strong commitment to international standards – Have working groups on medical software (only DITTA proposed a new item for consideration) – IMDRF to clearly indicate its goals and ambitions, and have an open attitude for industry's proposals and proposed contributions to achieve them. 9

IMDRF Management Committee (April 2012) Pleased that Management Committee open to greater industry involvement, however… IMDRF prefers one industry representative: – Not possible for one individual to fully represent entire industry – Our letter reaffirmed DITTA’s strength as the only global association representing medical imaging, which includes companies of all sizes all over the world – In an effort to promote industry unity, DITTA approached GMTA about preparing a joint response, they declined – As such DITTA has proposed it’s own representative DITTA submitted a New Working Item Proposal on Medical Software IMDRF Chair, Dr. Kelly, welcomed DITTA’s remarks and the Management Committee will discuss our letter at their next meeting on June 5,

Medical Software To further illustrate our commitment to IMDRF, DITTA prepared a New Work Item Proposal based on a IMDRF template at the request of the Management Committee to consider medical software as a future IMDRF work item DITTA is currently working to prepare another medical software workshop later this year after the successful workshop in Brussels last October

Other Activities DITTA will host a workshop on IEC third edition in China later this year with SFDA as part of the US China Joint Commission on Commerce and Trade (JCCT) DITTA is seeking to incorporate and is developing its own by-laws after a successful annual meeting last December at RSNA where we reached consensus among membership on an organizational and governance model – This includes scope, objectives, decision making and approval processes, criteria for membership, meeting guidelines, association priorities, etc. – DITTA association executives signed a commitment letter to further illustrate their pledge to support and strengthen DITTA Several DITTA member companies completed the WHO survey on “access to medical devices” 12

Conclusion DITTA is enhancing its network across the globe to better understand the needs of stakeholders and to support efforts in line with our focus and objectives DITTA is interested to learn more about WHO’s interests, and appreciates the invitation to continue this dialogue We look forward to expanding this important relationship in the interest of patient safety and access to advanced medical imaging technologies DITTA members are committed to support WHO initiatives for “safe, effective, and affordable technology for very low resource settings for use at point of care” 13

Thank You 14