www.globalditta.org

DITTAGLOBAL DIAGNOSTIC IMAGING, HEALTHCARE IT & RADIATION THERAPY TRADE ASSOCIATION

TowardsGlobal Efficiencyin Healthcare

DITTA was created in 2001 by four organisations: COCIR (Europe), JIRA (Japan), MEDEC (Canada) and MITA (United States). In 2012, it was incorporated as a non-profit trade association under the law of the state

of Delaware (USA) in order to allow growth and enable partnership in global regulatory fora. Since its inception, membership has grown significantly and today counts ten associations amongst its members.

DITTA is the united global industry voice for diagnostic imaging, radiation therapy, healthcare IT, electromedical and radiopharmaceuticals.

About DITTA

Our membership consists of industries, innovators and product developers responsible for designing and producing technologies such as:> Medical X-ray equipment> Computed tomography (CT) > Ultrasound> Nuclear imaging> Radiation therapy equipment> Magnetic resonance imaging (MRI)> Imaging information systems> Medical software, health IT and

electromedical> Positron emission tomography (PET)

and radiopharmaceuticals

These life-saving products:> Lead to the early detection of disease> Improve the quality of care> Reduce the likelihood of medical errors> Lower the long-term cost of health care

DITTA represents a global medical technology market worth over €100 billion annually.

Scope

Innovative technologies developed by DITTA membership are directly contributing to 1) better access to healthcare in order to reduce health inequalities, 2) better quality in order to reduce medical errors, and

3) increase efficiency for a better sustainability of healthcare systems.DITTA’s mission is to better communicate, coordinate and collaborate on matters of common interest and to work effectively at the global level with policy-makers, standardisation bodies, professional associations, scientific organisations and other key stakeholders.

DITTA advocates convergence of the regulatory environment at the global level, driving alignment, improving market access, and enhancing the global competitiveness of DITTA member companies.

Vision and Mission

Our Vision is: APPROVED ONCE, ACCEPTED EVERYWHERE

> Advocate for efficient policies and regulations that promote innovation for the benefit of both the patients and healthcare providers

> Communicate, cooperate and coordinate with its member associations

> Identify topics and trends with global industry impact

> Develop and submit joint industry positions> Promote ethical conduct and practices> Leverage the benefits of international standards

> Improve awareness and relevance of healthcare industry products and services

> Enhance global competitiveness of member companies

> Limit regulatory burden through the global harmonisation of regulatory frameworks

> Expand market access by removing technical, regulatory and trade barriers and streamlining clearance processes

RPS Regulated Product Submission Articulate the global industry opinion in effectively designing mechanisms to simplify and optimise product registration files

UDI Unique Device Identification Establish a global and simple way to identify devices through a unique set of requirements to enhance traceability of medical equipment

MSW Medical Software Share expertise in stand-alone medical software and contribute to a globally unified regulatory regime

GRP Good Refurbishment Practice Establish and promote good remanufacturing practice as the gold standard on equipment remanufacturing

ENVI Environmental Policy Support the United Nations activities (Basel Convention) on eWaste

MDSAP Medical Device Single Audit Program Simplify audit plans and avoid redundant work performed in various jurisdictions

> Since 2011, DITTA has been invited to twice-a-year meetings with WHO on various industry and technology projects

> As a recognized member of the IMDRF Stakeholders Group, DITTA participates in the IMDRF Management Committee meetings

> DITTA’s work item proposal on medical software was accepted by IMDRF in 2013. This was the first and only industry-led proposal accepted by IMDRF

With its extensive industry knowledge and key partnerships with international institutions and decision-makers, DITTA provides its members with invaluable early information and support, ensuring that their interests are represented at the international policy level. DITTA is currently partnering with:

Goals

Working groups

Main Achievements

Global Reach

Mirror Groups providing industry inputs into corresponding IMDRF work items

> IMDRF - International Medical Device Regulators Forum> WHO - World Health Organisation> AHWP - Asian Harmonization Working Party> World Bank

www.globalditta.org

> United, single and global voice for the medical and health Information and Communication Technologies (ICT) technology industry

> In-depth expertise on a broad range of topics and technologies

> Exchanging experience and competence with other stakeholders

> High visibility of top industry issues at international level

> Access to international high-level regulators and decision-makers

> Opportunities to meet and collaborate on removal of trade barriers and expand members’ market reach

> Promotion of the innovative medical and health ICT technology industry and its services globally

> Monitoring potential challenges and opportunities for its members

> Continuous surveillance of the regulatory, technical and trade environments and trends

Representing healthcare in 9 jurisdictions and caring for over 7 billion people

Contact the DITTA Secretariat 2013-2014 held by COCIR

Diamant Building, Boulevard A. Reyers 80, 1030 Brussels, BelgiumTel +32 (0)2 706 89 60 • Fax +32 (0)2 706 89 69

Email info@cocir.org

Benefits for DITTA Members

DITTA Global Presence

Not a member yet? Join DITTA today!