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Update from DITTA
01.29.14 DITTA Statements
The Regulatory Affairs Professionals Society (RAPS) and the Asian Harmonization Working Party (AHWP) held a Joint Medical Device Regulatory Conference on the 2–3 December 2013 in Selengor, Malaysia, near Kuala Lumpur.
The event brought together stakeholders involved the regulation of medical devices and medical technology from Asia and around the world.
On behalf of DITTA, Mr. Takahashi (former International Committee Chair of JIRA) made a speech on the last day of AHWP Main meeting.
The detailed event agenda is available here.
The presentations are available on the AHWP website.
01.06.14 DITTA Statements
The Second WHO Global Forum on Medical Devices ‘Priority Medical Devices for Universal Health Coverage’ was held on the 22-24 November 2013 in Geneva, Switzerland.
It provided the global public health community with opportunities for information exchange and collaboration to increase access to high-quality, safe, and appropriate priority medical devices.
The conference allowed end users and stakeholders from academia, international organizations, industry, and NGOs to share their experiences and challenges in providing access to medical devices.
DITTA Chair Nicole Denjoy attended the Forum, and gave presentations at various sessions, including contributions to workshops, on the topics of: regulating medical software, international standards, and non-communicable diseases.
The DITTA presentations are available here.
11.20.13 DITTA Statements
DITTA welcomes the progress made towards medical device regulatory harmonization at the 4th meeting of the International Medical Device Regulators Forum (IMDRF), chaired by the European Commission in Brussels, Belgium, on 12-14 November, 2013, under the leadership of Despina Spanou.
The IMDRF Management Committee reviewed the six Work Items during its meetings on 12 and 14 November, including draft guidance documents previously put in for public consultation. Several of these guidance documents have now been adopted and will be posted on the IMDRF website in the coming weeks. DITTA applauds all IMDRF members for these achievements, which will provide a basis for further regulatory convergence between the IMDRF jurisdictions.
DITTA engaged with IMDRF as an active partner throughout IMDRF. DITTA members participated in the Open Stakeholder Forum event on 13 November, which included an interactive afternoon session with stakeholder presentations on the theme “Innovation for Safety.” Nicole Denjoy, DITTA Chair and COCIR Secretary General, speaking at this stakeholder session, presented DITTA’s position on the challenges and opportunities facing the industry in this area, and drew the audience’s attention to the many opportunities for improved patient safety and economic growth offered by the prospect of international regulatory convergence for medical devices.
The 2014 IMDRF meetings will be hosted by the United States under the leadership of the Food and Drug Administration, starting with IMDRF-5 in San Francisco, USA, on 25-27 March, 2014.