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.

The Future of Health Preferences in Regulatory and Clinical Decisions

For those who are interested, Duke will be hosting a “Patient Voice” webinar on Tuesday at 17:00.

This presentation will give an overview of recent advances in health preference research. Specifically, it will show how the estimation of QALYs has evolved to incorporate time preferences; review the potential implication of PDUFA IV for benefit-risk analyses; discuss the importance of perspective in preference research (e.g., patient, societal, etc.); and introduce emerging infrastructure designed to advance support tools in preference-sensitive decisions, promoting clinical relevance. This presentation is for students, clinicians and scientists interested in health preference research and will aid understanding of ongoing research, educational, and policy initiatives as well as the state of the science and practice.

Contact Carolyn Hutyra to attend via WebEX: carolyn.hutyra@dm.duke.edu


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


CONITEC in Evidence: “Elaboration of Guidelines for Care of the Pregnant Woman”

We would like to inform you that the next video conference of the CONITEC Evidência program will be held on 07/11 (Monday) at 4:00 pm, with the theme “Elaboration of Guidelines for the Care of the Pregnant Woman” to be presented by Dr. João Batista Lima, Hospital Sofia Feldman.

To access CONITEC in Evidence, follow the guidelines below:


The video conference will be broadcast live over the Internet. To watch, go to the link http://datasus.saude.gov.br/index.php/multimidia or CLICK HERE and identify the session in the list of events. It is recommended to use the Internet Explorer browser.

To ask questions and make comments during the transmission, send an e-mail to conitec.evidencia@saude.gov.br.


5 Years of CONITEC


On 5 and 6 December, the event will be held in commemoration of the 5 years of the National Commission for the Incorporation of Technologies, Comissão Nacional de Incorporação de Tecnologias no SUS (CONITEC) in Portuguese, In Brasil

The different aspects of the Commission’s activity will be addressed in the scope of incorporation, exclusion or alteration of health technologies, in addition to the elaboration of clinical guidelines. Challenges and processes will be discussed with a view to ensuring a transparent and integrative action .

Deadline for registration: November 10, 2016.

To participate, access the link: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=28711 e preencha a ficha de inscrição

Attached follows the Event Schedule (only available in Portuguese) 


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