Washington DC, 5 September, 2019 (PAHO)- National Regulatory Authorities (NRAs) from 19 countries of the Americas met in Bogotá, Colombia, from 2-6 September, to jointly develop strategies and exchange initiatives to strengthen the regulation of medical devices in the Region of the Americas.
The meeting was hosted by the National Institute of Food and Drug Surveillance from Colombia (known in Spanish as INVIMA), and authorities from Argentina, Bolivia, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Trinidad and Tobago, United States, Uruguay, and Venezuela participated in the event.
"One of the main achievements of this Regional Working Group are the advances in capacity building and joint work, with concrete results, such as the construction of a Regional System for Exchanging reports of adverse events of medical devices," said Alexandre Lemgruber, Regional Advisor of Health Technologies at PAHO/WHO.
Lucia Ayala, Director of Medical Devices and other Technologies of INVIMA, said that "the meeting was essential to continue strengthening the health system in terms of medical devices and to strengthen the sanitary surveillance of these products so that they are marketed with quality, safety, and efficacy."
PAHO works jointly with NRAs to strengthen the regulatory system for medical products. In Colombia, PAHO and INVIMA developed several actions that include:
- II Internship in Premarket and Postmarket Surveillance of Medical Devices (2-4 September): 15 participants, representing 15 countries of the Region and selected among the best students of the virtual course on Regulation of Medical Devices, participated in the second edition of Internship on Premarket and Postmarket Surveillance of Medical Devices, sponsored by INVIMA.
- IX Meeting of the Authorities for the Strengthening of the Regulatory Capacity of Medical Devices (MD) in the Region of the Americas: an open session was organized (4-5 September) with a workshop on the Medical Device Single Audit Program, coordinated by the Food and Drug Administration (FDA). During this session, participants presented and discussed several topics, including MD nomenclature, MD cybersecurity, personalized MD, good regulatory practices, standards, and activities of the International Medical Device Regulators Forum. One hundred fifty people from the public, private and academic sectors participated in the meeting. On September 6, a closed session was held where regulatory authorities exchanged experiences in MD regulation. Countries presented their advances and challenges and discussed issues such as the regulation of MD maintenance, exchange of inspection records, and the REDMA program for the exchange of reports of adverse events. At the end of the meeting, participants defined the priorities for the 2020 Work Plan.