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Home Activities
Activities

Developing a Global Perspective in Industry

DITTA establishes Working Groups (WGs) where technical and subject matter experts from member associations and companies collaborate in important issues facing our industry. DITTA currently hosts 8 Working Groups to address a range of topics, including harmonization/convergence of medical device regulations, environmental policy, global health, and technical standards. These groups routinely and proactively engage and partner with key global organizations, decision makers, and the public to effectively communicate the perspective of industry.

Our activities key focus

Advocate an industry-friendly regulatory environment accelerating access to market

Support the convergence of regulatory frameworks

Promote the use of international standards

Develop constructive dialogues with regulators and other key stakeholders

Cooperate with international sister trade associations on issues of common interest

Monitor trends in fast-developing markets such as Brazil, Russia, India, China and Korea

Our activities working groups
Activities

Clinical Evaluation

The DITTA Clinical Evaluation (CE) Working Group contributes to the development of globally converged regulatory approach for the clinical evaluation and conduct of clinical investigations for medical devices.
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Activities

Cybersecurity

The DITTA Cybersecurity Working Group aims to facilitate international regulatory convergence on cybersecurity in medical devices. Besides contribution to relevant IMDRF and AHWP discussions on the topic, DITTA also serves as a platform for the exchange of industry best practices.
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Activities

Digital health & cybersecurity

DITTA aims to contribute to the convergence of globally harmonised regulatory approaches and monitors progress in various jurisdictions. DITTA shares industry best practices and guidelines that manufacturers can implement to improve their cybersecurity capabilities.
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Activities

Environmental policy

The DITTA Environmental Policy (ENVI) Working Group (WG) was created in 2012 to respond to the need of having a central focal point to follow the development of international environmental related legislation and to coordinate actions on international matters. The WG is coordinated by the COCIR office.
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Activities

Global Health

The DITTA Global Health (GH) Working Group (WG) is focusing on efforts towards WHO and their various groups (WHO Global Committee on NCDs) as well as ensuring  participation to annual World Health Assembly since DITTA granted in 2015 NGO status in official relations with WHO.
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Activities

Good refurbishment practice

The objective of the DITTA Good Refurbishment Practice (GRP) Working Group (WG) is to promote medical imaging equipment refurbished by Original Equipment Manufacturers (OEM), enabling market access where refurbished medical equipment is not used or banned by law to be imported and sold.
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Activities

Medical device single audit program

The DITTA Medical Device Single Audit Program (MDSAP) Working Group supports the development and implementation of a global harmonised system for quality management audit at international level.
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Activities

Medical Software & Artificial Intelligence

The DITTA Medical Software & Artificial Intelligence (MSW & AI) Working Group contributes to the development of globally harmonised regulatory approach for software of medical devices and related IT networks and monitors development in various jurisdictions.
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Activities

Regulated Product Submission

The DITTA Regulated Product Submission (RPS) Working Group is committed to support the creation of a harmonised structure and electronic platform for the registration of regulated products in multiple jurisdictions.
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Activities

Regulations & Standards

DITTA supports activities that aim at regulatory convergence at international level. We contribute to efficient policies and regulations that promote innovation for the benefit of both the citizens, patients and healthcare providers.
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Activities

Standardisation

The DITTA Standardisation (STA) Working Group’s purpose is to identify and explore ways to improve the international process of developping standards.
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Activities

Unique Device Identification

The DITTA Unique Device Identification (UDI) Working Group is committed to support global implementation of a uniform device identification system and monitor progress in various jurisdictions.
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