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 – RedETSA

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