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Alexandre Lemgruber

Explore the main accomplishments and obstacles in regulating medical devices in the Americas region. Learn about regional meetings, collaborations, capacity building efforts, exchange of adverse event reports, and the progress of the Regional Mapping project.

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Alexandre Lemgruber

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  1. Regulation of Medical Devices in the Region of the Americas: main achievements and challenges Alexandre Lemgruber

  2. Region Working Group on Medical Device Regulation • Established in July 2012 with 12 Regulatory Authorities • In 2018 the Regional Group has the participation of 23 countries:

  3. Regional Meetings • Regional meetings held in: Cuba (2012), Argentina (2013), USA (2014), Colombia (2015), Brazil (2016), Mexico (2016), Canada (2017) and El Salvador (2018) • Three meetings in conjunction with IMDRF • Two in conjunction with PANDRH Network • Joint activity with the Regional HTA Network - RedETSA • VIII Regional Meeting (2018): representatives from 21 Member States from the Region; Spain and Portugal as invited observers; two WHO Collaborating Centers (CECMED and University of Vermont)

  4. Collaborations • International Medical Device Regulators Forum – IMDRF: • Mirror groups: Adverse Events Reports, Software as a MD, Personalized Medical Devices • Participations in all IMDRF meetings since 2014 • Participation of ANMAT (Argentina) in the Personalized Medical Devices and Clinical Trials • PANDRH Network: for the first time a project on medical device regulation was developed, with the goal of strenghtening regulatory capacity in the Region • Ibero-American Network: joint meetings and collaboration on capacity building

  5. Capacity building • Essential functions for the regulation of medical devices (e-learning), developed by CECMED (Cuba), WHO/PAHO CC • 128 participants from 17 countries • Post-marketing regulation (e-learning), developed by INVIMA (Colombia) • 129 participants from 17 countries • English version to be launched in March 2019 • Short internships: first one in INVIMA (Colombia), with representatives from 9 regulatory authorities

  6. Exchange of Reports on Adverse Events of Medical Devices: REDMA Program • Secure exchange of reports on adverse events using a web system integrated to PRAIS • Operation and procedure documents based on IMDRF NCAR System • Secretariat: CECMED (Cuba), INVIMA (Colombia) and ANVISA (Brazil) • Pilot exercise completed, with the participation of 10 countries (Argentina, Brazil, Chile, Colombia, Cuba, Mexico, El Salvador, Panama, Dominican Republic and Uruguay); 12 reports exchanged • Full implementation by the first quarter of 2018

  7. Update of the Regional Mapping • First Regional mapping conducted in 2014, with results from 15 countries • New mapping as part of the first project on medical devices within PANDRH • Project coordinatedby INVIMA and CECMED, with PAHO as Secretariat • Resultsreceivedfrom 20 countries(Argentina, Belice, Bolivia, Brasil, Canada, Chile, Colombia, Costa Rica, Cuba, DominicanRepublic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, and Uruguay)

  8. Update of the Regional Mapping (2) • Mapping of the Regulation of Medical Devices in the Americas Region • Mappingtool • Sent to the NRA members of the PANDRH Network • Structured in 11 main categories. • Includes 47 questions. • Feedback received from 20 countries in the first phase

  9. Medical DevicesObservatory • Basic Indicators will be available in the Medical Devices Observatory within PRAIS

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