PA PAHO Updat ate Alexandre Lemgruber IMDRF Meeting Moscow, March 2019
PAHO/WHO RE REGIO IONAL WORK RKIN ING GROUP O P ON MEDIC ICAL D DEVIC ICE RE REGULATIO ION ESTABLISHED: July, 2012 with 12 countries; currently with 23. OBJECTIVE: Strengthen regulatory capacity and promote regulatory convergence for medical devices in the Region of the Americas. Argentina Belize Bolivia Brazil Canada Chile Dominican Colombia Costa Rica Cuba Ecuador El Salvador Republic Guatemala Honduras Jamaica Mexico Nicaragua Panama Trinidad & Paraguay Peru Uruguay Venezuela Tobago
PAHO/WHO REGIONAL MEETINGS ARGENTINA COLOMBIA CANADA 201 012 201 013 2014 14 2015 015 2016 16 2017 17 2018 018 CUBA USA BRAZIL EL SALVADOR MÉXICO VIII REGIONAL MEETING 22 – 23 OCTOBER 2018 - EL SALVADOR 22 October 23 October Regulators session Stakeholders forum - Hosted by DNM (NRA of El Salvador) - Advances and challenges, at national - Regulators session: 32 participants level, on Medical Device Regulation - Medical Device Cyber security representing 24 countries - Collaboration with IMDRF - Standards - International experiences (Spain and - Stakeholders forum: 90 participants - Postmarketing Surveillance for Medical Portugal) Devices in the US - Capacity building activities - 2nd Regional Meeting in conjunction with - Regulatory framework for medical - Update on the Mirror Groups & the PANDRH meeting devices in Europe Technical Groups - Definition of the 2019 Work Plan
PAHO/WHO COLLABORATION W WITH I IMDRF o REDMA Program on the exchange of post market safety information on medical devices was launched following a mirror group of the IMDRF working group on NCAR system o Creation of two new mirror working groups o Participation in the IMDRF Working Groups of Medical Device Clinical Evaluation and Personalized Medical Devices (Regional Working Group represented by ANMAT, Argentina) o Stakeholder forum in the Regional meetings
PAHO/WHO MIRROR WORKING GROUPS NCAR o Two new Mirror Exchange Software as Personalized Adverse Working Groups were Program: a Medical Medical Event created in the last REDMA Device Devices terminology Regional Meeting Program (October 2018) MINISTRY OF COFEPRIS, CECMED, ANMAT, HEALTH, COORDINATOR MÉXICO CUBA ARGENTINA URUGUAY
PAHO/WHO REDMA PROGRAM PILOT 10 PARTICIPANT COUNTRIES (ARG, DOCUMENTS BRA, CHI, COL, CUB, MEX, ELS, PAN, UPDATE OF THE PROGRAM’S DOR, URU); 12 REPORTS WERE OPERATIONAL AND PROCEDURAL EXCHANGED THROUGH A SECURE DOCUMENTS BASED ON IMDRF SYSTEM DEVELOPED BY CECMED DOCUMENTS. TRAINING IMPLEMENTATION ONLINE & LAUNCHED ON 14 MARCH 2019 FACE-TO-FACE SECRETARIAT CECMED (Cuba), INVIMA (Colombia) and ANVISA (Brazil)
PAHO/WHO REDMA PROGRAM o Secure exchange of reports on medical devices’ adverse events. o Fully integrated within the Regional Platform on Access and Innovation for Health Technologies (PRAIS). o Access only allowed to the NRA members of the REDMA Program. o Access to the web platform is done through a single contact designated by each NRA.
PAHO/WHO CA CAPACI CITY BUI BUILDING HEALTHCARE TECHNOLOGY POST-MARKETING SURVEILLANCE MANAGEMENT WORKSHOP (e-learning) - In collaboration with the University - Collaboration INVIMA-PAHO of Vermont - The Spanish version of the course - 27-29 March 2019 had two editions, with 90 - 20 participants from the Caribbean participants countries - First edition in English for the Caribbean countries - 7 Modules were translated into English: Technovigilance; London MEDICAL DEVICE REGULATION Protocol; Failure Mode and Effects (e-learning) Analysis; patient safety and clinical - Developed by CECMED risk management; Reuse and - Course had two editions, for a total reprocessing of medical devices; of 159 participants Signal generation; Intense - English version will be offered in surveillance and sentinel network . 2020 - Starting date: 13 May 2019
PAHO/WHO REGIONAL L REGULA LATORY PROF OFILE LE MODULES o Part of the first project on Medical M2 M4 Device Regulation at PANDRH; NATIONAL HUMAN coordinated by INVIMA and CECMED IMPORT GOOD REGULATORY RESOURCES with PAHO as the Secretariat. CONTROLS REGULATORY SYSTEM PRACTICES o Basic indicators tool M3 M1 Sent to the NRA members of the PANDRH Network. M7 M5 REGULATORY LICENSING Structured INSPECTIONS in 11 main POST- categories . MARKETING MARKETING M6 M8 Includes 47 questions. SURVEILLANCE AUTHORIZATION Self-assessment from 22 M10 countries. TESTING LABORATORIES IVDs CLINICAL TRIALS M9 M11
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