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

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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.