USFDA – IACRC Webinar Series on Medical Device: ISO 13485 and MDSAP
June 2, 10 and 17, 2021.
In June, the Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series. Sessions from the series focused on ISO 13485 and Medical Device Single Audit Program (MDSAP) outcomes utilization for regulatory purposes, where ANVISA and ANMAT, besides the USFDA share their experiences.
Presentations and recordings for each session available in English, Portuguese and Spanish:
Part I, 2 June 2021
Objective: Explain how medical devices inspections are conducted using the MDSAP model based on the ISO 13485, and how agencies may align to ISO 13485.
Presentation on Auditing Organization Assessment Program
Auditing Organization Assessment Program
Programa de avaliação da Organização de Auditoria
Programa de Evaluación de Organizaciones Auditoras
Presentation – ANVISA
Good Manufacturing Practices in Brazil: Resolution RDC 16/2013, similarities and differences compared to ISO 13485:2016
Boas Práticas de Fabricação no Brasil: Resolução RDC nº 16/2013, semelhanças e diferenças em comparação com a ISO 13485:2016
Buenas Prácticas de Fabricación en Brasil: Resolución Anvisa RDC nº 16/2013, similitudes y diferencias en comparación con la norma ISO 13485:2016
Part II, 10 June 2021
Objective: Present how an MDSAP audit is conducted and a case study to explain the audit model based on ISO 13485.
Case Study: Different approaches by the participating regulatory agencies vis a vis an MDSAP audit to highlight the similarities and identify areas of opportunity for alignment:
Case Study – Certification Agenda
Case Study MDSAP Audit Report
Caso de Estudo Relatório de Auditoria MDSAP – Partial Translation to Portuguese
Caso de Estudio Reporte de Auditoría MDSAP – Partial Translation to Spanish
Part III, 17 June 2021
Objective: Explain the MDSAP audit model, present the opportunities to leverage on MDSAP audit outcomes and provide the experience of an Affiliate Member on the process to become one and the benefits obtained.
Session Recordings – to be uploaded after the event:
USFDA – IACRC Webinar Series on Medical Device: ISO 13485 and MDSAP – Part III
USFDA – IACRC Webinar Series on Medical Device: ISO 13485 and MDSAP – Parte III
USFDA – IACRC Serie de Seminarios Web sobre Dispositivos Médicos: ISO 13485 y MDSAP – Parte III
FDA’s use of MDSAP Documents
O uso de documentos MDSAP pelo FDA
Uso del MDSAP por la FDA
ANMAT’s Experience as an MDSAP Affiliate Member
Experiência da ANMAT como Membro Afiliado do MDSAP
Experiencia de ANMAT como Miembro Afiliado de MDSAP
Opportunities to leverage MDSAP outcomes
Oportunidades para alavancar os resultados do MDSAP
MDSAP programa de miembros afiliados
National Health Institute of Chile
Regulation of Medical Devices in Chile: The challenge ahead. Experts from the FDA (United States), ANVISA (Brazil) and ANDID (Chile), convened by ADIMECH and the Coalition, analyzed their experiences and practices in regulatory matters.
Session Recording (Available in Spanish)
U.S. Food and Drug Administration – LatAm Office
U.S. FDA LAtin America Office, IMDRF: WGs and Priorities, MD Division (CDRH) & LatAm Activities, FDA Standards & Conformity Program/Policy and MDSAP & ISO13485.
Agenda, Slides deck FDA Presentation – Talking Points, Webinar Recording.
U.S. Food and Drug Administration
The Center for Devices and Radiological Health (CDRH) – FDA provides a web page for multimedia industry education. The modules available describe many aspects of medical device regulations covering both premarket and postmarket topics.