7th Meeting of the Regulatory Authorities for the Strengthening of the Medical Devices Regulatory Capacity in the Americas September 21 and 22, 2017 – Ottawa, Canada

The 7th Meeting of the Regulatory Authorities for the Strengthening of the Medical Devices Regulatory Capacity in the Americas was held in Ottawa, Canada, on 21 and 22 September 2017, within the framework of the IMDRF (International Medical Device Regulators Forum). Regulators from eighteen countries were represented: Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Cuba, Ecuador, El Salvador, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Dominican Republic, Trinidad and Tobago and Uruguay.

The objectives of the Regional Meeting on the Regulation of Medical Devices were focused on strengthening the Regulatory Capacity of the NRAs (National regulatory authorities) of the Region of the Americas in the field of medical devices, through the establishment of strategies to achieve joint objectives, exchange of experiences and strengthening collaboration between countries.

On the first day the meeting was open to invited guests, including representatives from regulatory authorities from outside the Region and from the regulated sector. On the second day the meeting was restricted to representatives of the regulatory authorities that make up the Regional Working Group on Regulation of Medical Devices. Below you can find the agenda of the two meeting days, as well as the links to access the presentations.

September 21

1. Welcome, Introductions and Review of Workshop Schedule
(Alexandre Lemgruber – PAHO)

2. The Use of Medical Devices in Public Health Programs
(Rosanna Peeling, IDC / LSHTM)


3. WHO Global Model Regulatory Framework for Medical Devices
(Mike Ward – WHO)


4. Asian Harmonization Working Party Playbook
(Dr Jeong-Rim Lee, AHWP and Ministry of Food and Drug Safety-MFDS, Republic of Korea)


5. Medical Devices Regulations in the Americas – The Regulators’ Perspective

The experience of COFEPRIS, Mexico
(Norma Morales)


The experience of DNM, El Salvador
(José Vicente Coto)

6. Medical Devices Regulations in Americas – The Manufacturers’ Perspective
(Nicole Taylor Smith – Johnson & Johnson)


7. Use of Standards for Regulatory Purposes

The experience of USA (Sharon Lappalainen – FDA)


The experience of Cuba (Dulce María Martinez – CECMED)


8. Standards Alliance Survey
(Carlos Gouvêa , ALADDIV)


9.Session Review and Next Step
(Alexandre Lemgruber – OPS)

September 22

1. Opening remarks
(Health Canada and PAHO)

2. Progress since the VI Regional Meeting and objectives of the VII Regional Meeting
(Alexandre Lemgruber – PAHO)

3. Progress at National level on Regulation of Medical Devices since the VI Regional Meeting: all countries

(María Cecilia López Gutiérrez – Instituto de Salud Pública de Chile)


(Elkin Hernán Otávaro Cifuentes – INVIMA)


(María Auxiliadora Vargas de Dentice – Ministerio de Salud Pública y Bienestar Social)


(Julio Américo Salas Carnero – Ministerio de Salud)


Dominican Republic
(Escarlen Heredia – Ministerio de Salud Pública)


4. Report on the Virtual Training Courses

(Elkin Otálvaro Cifuentes – INVIMA, Colombia)


(Dulce María Martinez – CECMED, Cuba)


5. Panel on Medical Device Nomenclature
(Adriana Velázquez Berumen – WHO, videoconference, and Monica Cristina Duarte – ANVISA, Brasil)

6. REDMA Exchange Program of Post Market Safety Information on Medical Devices: update from the Secretariat
(Dulce María Martínez – CECMED, Cuba)


7. Update on the Medical Device basic indicators and the Assessment Tool for the Regulatory Capacity on Medical Devices
(Alexandre Lemgruber – PAHO)

8. Report on the PANDRH Project on Medical Device Regulation
(Elkin Hernán Otálvaro Cifuentes – INVIMA, CECMED)


9. Reprocessing of single use medical devices: current situation and next steps for the Technical Group
(Elkin Otálvaro Cifuentes – INVIMA, Colombia)


10. Discussion of proposals for the 2018 Working Plan of the Regional Working Group on Medical Device Regulation

11. Closing

x congresso

Brazilian Congress of Epidemiology

The next Brazilian Congress of Epidemiology offers pre-congress courses with low cost and topics of interest to ATS. We highlight:
1- Strategies to Improve the Visibility of Scientific Activities and Expand the Impact of Research (Juliana Reis – Fiocruz)
2 – Writing and Scientific Publishing (Prof. Mauricio Pereira – UnB and Leila Posenato Garcia – Ipea)
3 – Review of Scientific Articles (Prof. Leopoldo Antunes – USP and Prof. Maria Amelia Veras – FCMSCSP)
4 – Maximize the Impact of your Research and Attract Collaborations: Use Reporting Guidelines for the Writing of Research Papers (Iveta Simera – Univ Oxford and EQUATOR Network) – this course will be in English
5 – Contemporary Topics on Scientific Integrity and Ethics in Publications (Sonia Vasconcelos – UFRJ)
6- How to write and publish scientific articles (Laura Rodrigues – London School of Hygiene & Tropical Medicine.
7-Evidence-Based Guidelines – Arn Migowski, Airton Stein and Marisa Santos – INC
The complete list of courses is available at: http://epi.org.br/cursos/index.php#topo

 Registration will be limited to the first registrants, within the number of vacancies offered.


International Workshop on MDCA

An International Workshop on Multi-criteria Decision Analysis (MCDA) was organized on May 15, 2017. The event was organized by NATS-National Institute of Cardiology and counted on the participation of João Bana e Costa, an engineer who carried out a practical workshop with the M-Macbeth software. The method is promising and has been studied by NATS to support complex decisions. Members of NATS from IFF, INTO, INC and DGITS Ministry of Health were present.

RedETSA Meeting, San Salvador, El Salvador – October 2017


The VIII Meeting of the Health Technology Assessment Network of the Americas (RedETSA) took place on October 5, 6 and 7, 2016 in the city of San Salvador, El Salvador. Although it was estimated that about 100 participants would attend the meeting, there were more than 200 participants coming from 28 institutions from 14 countries in the region. The meeting allowed to introduce the relevant actors of the health system of El Salvador into the key concepts of health technology assessment (HTA ); Discuss and develop relevant topics and share experiences between RedETSA members and invited experts; Share the advances and challenges of the members of the Network and define a work plan for 2017. The meeting was divided into three different sections over three days: an introductory session, the Redetsa meeting in conjunction with the National HTA Forum Of El Salvador and the Regional Meeting of HTAi and a closed meeting for the RedETSA member countries. 

Day 1 – Introductory Session

  • The first section was the introductory session in which the themes developed were on the key concepts of health technology assessment, the importance of HTA for universal health coverage. In the afternoon of the first day topics such as economic evaluation and its importance for decision-making and capacity mapping were discussed.

Day 1 y 2 – Meeting of RedETSA, National Forum of HTA in El Salvador, HTAi

  • The next section included the national HTA forum in El Salvador in addition to the HTAi regional meeting. Topics discussed during this session, amoung others, were progress in the institutionalization of HTA in the Americas, decisions on high-cost drugs, drug prosecution and cases of success in the use of HTA .

Day3 – Closed Meeting

  • The last section of the event was a closed meeting for RedETSA members. It was attended by 28 participants who represented 23 institutions. The countries represented were Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Peru and Uruguay. Also participated the Andalusian School of Public Health, of Spain. The session focused on the discussion of the activities carried out in 2016 and the main achievements of the countries during the year. Topics also included the website update, exchange program and priorities for 2017.

Each presentation and corresponding power points are available, in spanish, at http://www.salud.gob.sv/foroets-salud-sv/ or on our web page of RedETSA


RedETSA Professional Exchange Program – Canada

Professional Exchange Program 

Montréal and Ottowa, Canada – November 2016


L’Institut national d’excellence en santé et en services sociaux (INESSS), the National Institute of Excellence in Social Services and Health in english, is an independent organization reporting to the Minister of Health and Social Services of Québec. INESSS mission is to promote clinical excellence and efficient use of resources. It does so by issuing recommendations for adoption, its use or the coverage of the public system, and develops clinical practice guidelines to ensure optimal use.


The Canadian Agency for Drugs and Technologies in Health (CADTH) is an independent, nonprofit organization responsible for providing health care decision makers with objective evidence to help make informed decisions about the optimal use of health technologies.


In November 2016, the technical exchange of representatives of RedETSA member institutions at INESSS, Montreal and CADTH, Ottowa, was successfully completed. Thirteen professionals from 7 countries of the Region (Argentina, Brazil, Chile, Cuba, Mexico, Peru, Uruguay) and PAHO participated in the visit. The objective was to learn about the experience of INESSS and CADTH in the process of making coverage decisions in Quebec and Canada, respectively, and to know in detail how the different programs of both institutions are carried out. The professionals spent two and a half days at the INESSS headquarters in Montreal, where conferences and workshops were held with the institution’s experts. At the end of the third day they went to Ottawa, where they participated in a day of presentations and round tables with experts from CADTH. Important information was shared and methodological documents were provided for further study. Participants will keep in touch with professionals from INESSS and CADTH to further strengthen the link between institutions.

The professionals who participated in the meeting are detailed in the following table:


“Un intercambio de experiencia profesional es una instancia muy intensa y desafiante para generar nuevas relaciones, inspirar ideas, fortalecer lazos y nuevas estrategias, y recordar que no estamos solos en nuestro intento por dar mejor oportunidades de salud a la región. Eso fue lo que en lo personal ocurrió durante mi visita a INESSS de Montreal y a CADTH de Ottawa.” – Jorgelina Alvarez- Representante de RedArets- Argentina

“La visita técnica al INESSS y la CADTH ocurrió en un ambiente de gran apertura, comunicación, cordialidad y disposición de colaboración por lo que los asistentes pudimos conocer las mejores prácticas y experiencias internacionales en evaluación clínica, económica y social de tecnologías sanitarias (específicamente de medicamentos y de dispositivos médicos) así como de los procesos de transferencia del conocimiento y del involucramiento de pacientes, en la toma de decisiones.” – Esteban Hernández San Roman – México – CENETEC

To access the presentations from the event please click here


October 21 – Global Clinical Engineering Day

First edition: Global Clinical Engineering Day


On October 21, 2016, the first Global Clinical Engineering Day will be celebrated around the world. On that day, for 24 hours, the website http://global.icehtmc.com will feature interviews with members of the CE community, highlighting associations function from around the world such as ACCE, chat room in different languages, and streaming videos showing off various CE roles and functions.

For more information: Agenda Global Clinical Engineering Day


RedETSA Professional Exchange Program – Colombia

Visit of the Representatives of Member Institutions of RedETSA to the Health Technology Assessment Institute (IETS) in Bogota, Colombia


The Instituto de Evaluación Tecnológica en Salud (The Institute of Technological Evaluation in Health)  is the only institution in Spanish-speaking America of mixed participation and private character whose mission is to promote research in health technology assessment and contribute to the development of better health care practices.


On the 16th, 17th and 18th of August 2016, the technical exchange of representatives of RedETSA member institutions in the IETS was successfully completed. The visit took place at the IETS headquarters in Bogota, Colombia. Fifteen professionals from 8 countries of the Region participated in the visit, which was divided into keynote sessions and workshops related to specific topics.

Professional exchange helped strengthen the Network’s capabilities, as well as promoting the exchange of information, training and successful experiences in evaluations of technologies and derivatives. Specifically, the objectives were to learn about IETS’s experience in the process of evaluating health technologies and their role in decision-making, to learn about IETS’s experience in developing clinical practice guidelines and to carry out other activities that allow the exchange Of knowledge with the other representatives of the attending institutions

The professionals who participated in the meeting are detailed in the following table:



The participating professionals were very satisfied with the development of the activity; It was highly successful and beneficial both to them and to the institutions of which they are members, as shown by the following comments:

“O intercâmbio […] proporcionou uma rica troca de experiências entre os países participantes, permitindo o compartilhamento das experiências exitosas e das dificuldades enfrentadas no processo de avaliação de tecnologias em saúde e no desenvolvimento de Guias de Práticas Clínicas, promovendo o estreitamento dos laços e fortalecendo a capacidade de trabalho em rede nas Américas.”
Jorgiany Souza Emerick Ebeidalla

“[…]esta visita de intercambio técnico fue muy provechosa, en donde todo el equipo del IETS estuvo dispuesto a compartir su gran conocimiento y experiencia con nosotros y nos brindaron información muy detallada y precisa de su quehacer. Sin duda alguna este tipo de actividades representan un gran insumo para avanzar, sobre todo para países emergentes en el tema de ETS como Costa Rica.”
Ana Eduviges Sancho

“conocer la experiencia exitosa de Colombia en cuanto a Evaluaciones de Tecnologías en Salud (ETES), Medicina Basada en Evidencia y el desarrollo de Guías de Práctica Clínica, ha sido de gran importancia para nosotros como El Salvador, porque estamos en el Proceso de consolidar la Reforma de Salud y es de gran relevancia, realizar las evaluaciones de tecnologías que nos permita darle respuesta a las exigencias de nuevas tecnologías, a través de búsquedas sistemáticas y rápidas de literatura y de Evidencia Científica, que nos permitan disminuir la variabilidad injustificada en la práctica clínica, así como mejorar la toma de decisiones en Salud, para llegar a un nivel en el que podamos definir necesidades con Medicina Basada en Evidencia.”
Dr. Igor Castro Ramirios

“La experiencia de intercambio profesional me pareció excelente. El IETS nos dio a conocer como se formó el Instituto y como éste a través de su trabajo se ha incorporado como un actor muy relevante tanto para la sociedad y las autoridades de salud colombianas. Fue muy provechoso, conocer también las dificultades que tuvieron al momento de construir sus productos y al realizar sus procesos de evaluación de tecnologías sanitarias. De este modo, es posible prevenir o al menos estar preparados para cuando, en nuestros países, pensemos en generar algo similar. Además los anfitriones fueron muy acogedores y aclararon todas nuestras dudas.”
– Victoria Hurtado




Seminar – “Pricing and other comprehensive strategies to improve access to medicines”

“Pricing and other comprehensive strategies to improve access to medicines”

LSE pricing

On January 22nd, Professor Panos Kanavos, from the London School of Economics and Political Science (LSE), was the main speaker of the Seminar ” Pricing and other comprehensive strategies to improve access to medicines”, organized by the Department of Health Systems and Services, Unit of Medicines and Health Technologies (PAHO).

*The presentation is not part of the official RedETSA Webinars Program*

Seminar – “Pricing and other comprehensive strategies to improve access to medicines”


Seminar “Pricing policies and other strategies to improve access to medicines”

The Department of Health Systems and Services, Medicines and Health Technologies Unit of the Pan American Health Organization organizes the Seminar Pricing Policies and other Strategies to Improve Access to Medicines. The central conference will be led by Professor Panos Kanavos of the London School of Economics and Political Science (LSE).

The Seminar will be held on January 22 at 10:30 am, Wahington, DC time.
Those interested can attend the same via WebEx using the following link: https://paho.webex.com/meet/hta.

Presentations will be in English and there will be no translation.

Agenda – January 22

10:30 Opening remarks (Isabella Danel – Deputy Director PAHO)

10:45 -12: 15

Moderator: James Fitzgerald – HSS Director
Introduction: Analía Porrás (Head of Unit – HSS / MT)
Conference: Panos Kanavos (Deputy Director – LSE Health)
Comments: Amanda Glassman (Director of Global Health Policy – Center for Global Development)

12: 15-13: 00 Discussion
13:00 Closing

Panos Kanavos (BSc, MSc, PhD) is Professor of International Health Policy at the Department of Social Policy at the London School of Economics (LSE) and Program Director of the Medical Research Technology Group (MTRG) ) At LSE Health. He was a Harkness Fellow in Health Care Policy at the Department of Ambulatory Care and Prevention, Harvard Medical School. She is an economist by profession, currently coordinates the Program on International Health Policies at the LSE and teaches Health Economics, Pharmaceutical Economics and Policy, Health System Finance, and Health System Performance Indicators.
Panos Kanavos led the activities of MTRG, which is a research unit comprising 11 researchers at LSE Health, focusing on interdisciplinary and comparative research of medical technology policies. The group follows the following research currents:
– The economics of medical technologies, in particular drugs and medical devices;
– Prescription, relevance and quality of care;
– Access to developing medical technologies and economies in transition; Y
– Management of disease and the effectiveness of policies in medical technology.
As part of its activities, MTRG administers the Program on Pharmaceutical Policy Issues (PPPI), the Medical Devices Program, participates in and conducts studies sponsored by the European Medicines Information Network (EMI) -net, participates in the network for the study of rare diseases (BURQOL-RD), and is a member of the European Institute of Health Technology for Socio-economic Research (EHTI, for its acronym in English). It also coordinates the activities of the Patient Academy, an initiative between academia, health care regulatory agencies and patient groups.

Panos Kanavos has served as an advisor to a number of international governmental and non-governmental organizations, including the European Commission, the European Parliament, the World Bank, the World Health Organization, the Organization for Economic Co-operation and Development, the American Returnees and ministries of health in more than 21 countries in transition and in development. He has participated in the European Forum of Pharmacists as an advisor to the European Commission – Directorate-General for Enterprise and was part of the Commission’s reflection process on the economic aspects of medical devices.


Amanda Glassman is the program vice president, global health policy director, and senior fellow at the Center for Global Development, leading work on prioritization, resource allocation and value-for-money relation in global health, with a particular interest in vaccination. He has 20 years of experience working on health and social protection policies and programs in Latin America and other developing countries. Prior to her current position, Amanda Glassman served as technical director for health at the Inter-American Development Bank (IDB), where she led health economics and knowledge finance products and political dialogue with member countries, designed the grant program Based on “Salud Mesoamérica 2015” and served as team leader for conditional transfer programs such as Oportunidades de México and Colombia Familias en Acción.
Since 2005-2007, Amanda Glassman has been the associate director of the Global Health Financing Initiative in Brookings and has conducted research on health care effectiveness and domestic financial policies in low-income countries. Prior to joining the Brookings Institution, Amanda Glassman designed, supervised and evaluated health and social protection loans at the IDB and worked as a Population Reference Bureau Fellow at the United States Agency for International Development. She holds a master’s degree from the Harvard School of Public Health and is a graduate of Brown University.

iahpr destaque

Meetings of the International Academy of Health Preferences Research

2nd  Meeting of the International Academy of Health Preferences Research

On September 29, 2015 was held the 2nd Meeting of the International Academy of Health Preferences Research featuring the presentation of numerous exponents of the area as Dr. Jan Ostermann, Dr. Kathleen Marie Beusterien, Dr. Dean A. Regier, and Dr. Terry Nicholas Flynn. The event was held in Queensland, Australia, chaired by Dr. Emily Lancsar from Monash University. The event featured the presentation of members as Dr. Joel Hay, Dr. Benjamin M Craig, Dra. Kristen Howard, Dra. Jennifer A. Whitty and John F. Bridges.

3rd Meeting of the International Academy of Health Preferences Research

On October 18, 2015 was held the 3rd Meeting of the International Academy of Health Preferences Research in St Louis, USA, chaired by Dr. Derek Brown from Washington University. The event featured the presentation of numerous exponents of the area as Dr. Jan Ostermann, Dr. Kathleen Marie Beusterien, Dr. Dean A. Regier, and Dr. Terry Nicholas Flynn.

More information available on the International Academy of Health Preferences Research page on the link http://www.iahpr.org/