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 in collaboration with the Federal Commission for Protection against Sanitary Risks, COFEPRIS, have organized an open workshop on ISO 13485 Certification. During this event, the role of the Regulatory Authority and the Certification Bodies on the issuance and utilization of the Certificates will be discussed, as per the draft agenda that is available here.

Agenda-ISO-13485-Workshop-COFEPRIS-EN-12May22

REGULATORY COALITION PRINCIPAL MEMBERS