PAHO/WHO Collaborating Centre Regulation of Medical Devices

1. 4th WHO Global Forum on Medical Devices “Increasing access to medical devices” 13-15 Dec 2018,Visakhapatnam, Andhra Pradesh, India PAHO/WHO Collaborating Centre Regulation of Medical Devices Eng. Dulce María Martínez Pereira Assistant Manager Medical Devices CECMED

2. Experiences in the application of strategies for REGULATORY PROGRAM FOR MEDICAL DEVICES • systemic and harmonic character • flexible to our realities • taking international tendencies into account • and scientific & technical collaboration • interrelationships and responsibilities of stakeholders • communication and constant technical improvement both regulators and staff related to medical devices • impact in health

3. approval of Sanitary Register • certifications that authorize the operation of factories • requirements of the import and export of medical devices • regulatory audits by the authority • improvement of the role of post-market surveillance with scope to the use of medical devices in health care services MARKET IMPACT

4. Collaborating Centre PAHO/WHO for the Regulation on Health Technology (CUB-26) 1rst designation: 2014-2018 re-designation: 2018-2022 • Strengthening the regulatory capacity of medical devices in the Region of the Americas • jointstrategies • consensus • constantcomunication • sharedresults • PANDRH

5. TOR 2018-2022 • Strengthening of the Health Authorities Network for the regulation of medical devices, facilitating effective and timely exchange of regulatory information between countries in the region • To improve the capacity in the region on regulation of medical devices through educational activities, development and dissemination of resource materials regarding medical devices regulatory issues • To provide technical assistance to support the strengthening of the quality, safety and efficacy of medical devices at the global, regional and national levels • To participate in collaborative studies and to conduct regulatory research according to WHO priorities • To collaborate on the preparation and execution of training and educational activities on quality assurance and radiation protection of radiation medicine services (diagnostic imaging, radiotherapy and nuclear medicine services)

6. Given lectures of the virtual course on regulation of medical devices (CECMED - two editions) • 17 countries (Belize, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Spain, Guatemala, Honduras, México, Panamá, Paraguay, Perú, Dominican Republic, Uruguay, Venezuela) • obtained academic results above 98% • trained the staff of the regional regulatory authorities represented by 128 students INVIMA/CECMED - PANDRH project “Strengthening of regulatory capacity on medical devices in the Region of the Americas

7. Completed the mapping of opportunities and needs for capacity building on regulation of medical devices in the region • sixteencountriessurveyed • repliesreceivedfrom ten countries: Brazil, Mexico, Colombia, Panama, El Salvador, Chile, Ecuador, DominicanRepublic, Paraguay and Cuba • elaboratedreport • identified opportunities and training needs in regulatory issues of medical devices in the region

8. Program of Exchange of Reports of Adverse Events in the Region of the Americas (REDMA Program / NCAR mirror group) • discussed the strategy with countries of the region and established the bases of the REDMA program • automated system through the internet proved in pilot phase (10 NRAs registered) - total functionality of the web system, with high user satisfaction, recognizing it as a safe and effective • migration of the REDMA web system database to the PAHO server • repository of medical devices adverse events reports

9. The REDMA systemwasdevelopedtoallowtheexchange of reports of adverse eventsorincidents in medical devicesamongtheNRA of theRegion of theAmericas. Thisrepresents a proactivecommunicationsystemthatimpliesthepossibility of makingdecisionsbasedonsecurityinformationquickly Althoughthe data exchangeprocessusing REDMA isnot open tothepublicand will be restrictedamongtheparticipatingNRAsof thesystem, regulatoryactionsofficiallypublishedbytheARNs are accessible. REDMA wasdevelopedbythePAHO/WHO CollaboratingCenterin Cuba Furtherinformationpleasecontactredma@cecmed.cu

10. Regional mapping - instrument of basicindicators • Toevaluatethecurrentsituation of theRegulation of medical devices in thecountries of theRegion of theAmericas • Appliedinstrumentto18 countriesof theRegion • 11 modules with 47 basicindicators • Results will be posted on the Medical Devices Observatory within PRAIS • Todevelop Regional RegulatoryProfile INVIMA/CECMED - PANDRH project “Strengthening of regulatory capacity on medical devices in the Region of the Americas

11. CANADA CUBA DOMINICAN REPUBLIC MEXICO HONDURAS BELIZE NICARAGUA COLOMBIA EL SALVADOR PANAMA BRAZIL ECUADOR PERU BOLIVIA PARAGUAY URUGUAY CHILE ARGENTINA

12. Preliminaryresults

13. Goals Regulatory strengthening in the Region • Build a regional folder for capacitation on medical devices regulation • Translate editions of the virtual course on regulation of medical devices to English • Create a Community of Practice in the PRAIS Platform for members of the REDMA program • Official start of the integral operation of the REDMA Program - Launch expected for 15 Jan 2019 • To point to a regional regulatory perfil for medical devices