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

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: Argentina Belize Bolivia Brazil Canada Chile Colombia Costa Rica Cuba Ecuador El Salvador Guatemala Honduras Jamaica Mexico Nicaragua Panama Paraguay Peru Rep Dominicana Trinidad & Tobago Uruguay Venezuela

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)

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

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

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

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 coordinated by INVIMA and CECMED, with PAHO as Secretariat Results received from 20 countries (Argentina, Belice, Bolivia, Brasil, Canada, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, and Uruguay)

Update of the Regional Mapping (2) Mapping of the Regulation of Medical Devices in the Americas Region Mapping tool 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 Modules 1. Human Resources 2. Good Regulatory Practices 3. National Regulatory System 4. Import controls 5. Marketing Authorization 6. Licensing 7. Post-marketing Surveillance 8. Regulatory inspections 9. Testing laboratories 10. Clinical Trials 11. IVDs

Medical Devices Observatory Basic Indicators will be available in the Medical Devices Observatory within PRAIS