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.

Session I

Agenda

Recording

Presentations

Introduction and General Overview of Good Regulatory Practices – Renata Amaral – IACRC – LATAM – Coming soon
Diagnostics and Awareness of International Trade Treaies – Ricardo Aranda – Dorantes Advisors – Mexico
Mexico’s International Obligations – N. Viviana Salgado – Secretaría de Economía – Mexico
Mexico’s International Obligations – Juan A. Dorantes – Dorantes Advisors – Mexico

Session II

Agenda

Recording

Presentations

Good Regulatory Practices in Medical Device Regulation – Agnes S. Kijo – WHO – Global
Quality Infrastructure Law – Juan Carlos Rivera – DGN – Colombia
COFEPRIS – Status of Implementation of Good Regulatory Practices – Helga Castillo – COFEPRIS – Mexico

Session III

Agenda

Recording

Presentations

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

Session IV

Agenda

Recording

Panelists’ Bios – coming soon!

REGULATORY COALITION PRINCIPAL MEMBERS