PAHO/WHO Collaborating Centre Regulation of Medical Devices 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

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

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

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 joint strategies consensus constant comunication shared results Regional WG for MD NRAs CC PANDRH

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)

INVIMA/CECMED - PANDRH project 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

Completed the mapping of opportunities and needs for capacity building on regulation of medical devices in the region sixteen countries surveyed replies received from ten countries: Brazil, Mexico, Colombia, Panama, El Salvador, Chile, Ecuador, Dominican Republic, Paraguay and Cuba elaborated report identified opportunities and training needs in regulatory issues of medical devices in the region

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

The REDMA system was developed to allow the exchange of reports of adverse events or incidents in medical devices among the NRA of the Region of the Americas. This represents a proactive communication system that implies the possibility of making decisions based on security information quickly Although the data exchange process using REDMA is not open to the public and will be restricted among the participating NRAs of the system, regulatory actions officially published by the ARNs are accessible. REDMA was developed by the PAHO/WHO Collaborating Center in Cuba Further information please contact redma@cecmed.cu

Regional mapping - instrument of basic indicators To evaluate the current situation of the Regulation of medical devices in the countries of the Region of the Americas Applied instrument to 18 countries of the Region 11 modules with 47 basic indicators Results will be posted on the Medical Devices Observatory within PRAIS To develop Regional Regulatory Profile INVIMA/CECMED - PANDRH project “ Strengthening of regulatory capacity on medical devices in the Region of the Americas

Good Regulatory Practices PANAMA DOMINICAN REPUBLIC MEXICO EL SALVADOR ECUADOR CHILE PERU BELIZE ARGENTINA URUGUAY BOLIVIA HONDURAS PARAGUAY BRAZIL CANADA COLOMBIA CUBA NICARAGUA Module I Human Resources Module II Good Regulatory Practices Module III National Regulatory System Module IV Import Controls Module V Marketing Authorization (Registration) Module VI Licensing Module VII Postmarketing Surveillance Module VIII Regulatory Inspections Module IX Testing Laboratories Module X Clinical Trials Module XI In Vitro Diagnostics (IVD)

All participating countries have establish: Preliminary results All participating countries have establish: Few countries have: sanitary registration or other authorization of the ARN for the commercialization of the medical devices in the country the adoption of an official medical device nomenclature system scope, functions, attributions and responsibilities of the ARN requirements that require compliance with ISO 13485 responsibilities of the manufacturer and / or its authorized representative, importers, distributors, suppliers; with the post-marketing surveillance inspection of foreign establishments engaged in the manufacture of medical devices inspections of national establishments an official control laboratory for medical devices

Regulatory strengthening in the Region 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