Webinar Series on Good Regulatory Practices and Its Implementation in the Medical Devices Sector in Mexico
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Webinar Series on Good Regulatory Practices and Its Implementation in the Medical Devices Sector in Mexico
The Inter-American Coalition for Regulatory Convergence, Medical Technology Sector, under the Medical Device Regulatory Convergence Project (MDRC) within the Standards Alliance initiative, where USAID, ANSI and AdvaMed participate, and in collaboration with the Federal Commission for Protection Against Sanitary Risks (COFEPRIS), held a Series on Good Regulatory Practices and Its Implementation in the Medical Device Sector, which took place on 27 October, 10, 17 and 24 November, 2021.
These training intended to promote, through the exchange of experiences, the utilization of Good Regulatory Practices in the process to implement international standards with regulatory purposes for Medical Devices. This event was delivered in four webinar sessions, including an overview of international commitments, Good Regulatory Practices under the international and local scope of medical devices, regulatory processes in Mexico and challenges and opportunities for regulatory convergence in the medical devices sector.
The Process to Development of Technical Regulations for Medical Devices and In vitro Diagnostics and the warranty to comply with international obligations:
Part I
Regulation on Health Supplies – Jonathan R. Flores – CAS, COFEPRIS – Mexico
Official Mexican Norms – Victor Torres – DGN – Colombia
Part II
Regulatory Process at COFEPRIS – Berenice Terrazas – CGJC, COFEPRIS – Mexico
Mexican Pharmacopeia – Supplement on Medical Devices – Rafael Hernández – FEUM – Mexico