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:
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

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

8. 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)

9. 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

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